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Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645395
Recruitment Status : Terminated (Sponsor decision)
First Posted : August 24, 2018
Results First Posted : August 16, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Molecular Templates, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-hodgkin Lymphoma
Intervention Drug: MT-3724
Enrollment 9
Recruitment Details This two-part [Part 1: Dose Escalation and Part 2: maximum tolerated dose (MTD) Expansion Cohort] study evaluated the safety and tolerability of MT-3724 in combination with Lenalidomide (LEN) in participants with relapsed or refractory CD20 positive B-cell Lymphoma.
Pre-assignment Details Total 9 participants were enrolled in the study. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description Participants were administered MT-3724 10 micrograms per kilograms/dose intravenously (mcg/kg/dose IV) on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Period Title: Part 1 (Up to 6 Months)
Started 3 3 3 0
Completed 1 0 0 0
Not Completed 2 3 3 0
Reason Not Completed
Adverse Event             1             0             0             0
Disease Progression             0             1             0             0
Withdrawal by Subject             0             0             1             0
Sponsor's decision to close the trial             1             2             2             0
Period Title: Part 2 (Up to 6 Months)
Started 0 0 0 0
Completed 0 0 0 0
Not Completed 0 0 0 0
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN Total
Hide Arm/Group Description Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 0 9
Hide Baseline Analysis Population Description
Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 0 participants 9 participants
62.3  (8.33) 61.3  (8.33) 71.0  (12.77) 64.9  (9.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 0 participants 9 participants
Female
3
 100.0%
1
  33.3%
2
  66.7%
6
  66.7%
Male
0
   0.0%
2
  66.7%
1
  33.3%
3
  33.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 0 participants 9 participants
Black or African American
1
  33.3%
1
  33.3%
1
  33.3%
3
  33.3%
White
2
  66.7%
2
  66.7%
1
  33.3%
5
  55.6%
Other
0
   0.0%
0
   0.0%
1
  33.3%
1
  11.1%
1.Primary Outcome
Title Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity
Hide Description An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention. A DLT is any TEAE that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included participants who received at least one dose of any study drug (either MT-3724, or lenalidomide). Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 3 3 3 0
Measure Type: Number
Unit of Measure: participants
TEAEs 3 3 3
SAEs 1 1 1
DLT 0 2 0
2.Primary Outcome
Title Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters
Hide Description Laboratory parameters included hematology, blood chemistry, and urinalysis. Any abnormal laboratory test results which were considered clinically significant by the investigator were recorded on the case report form. Number of participants with any clinically significant abnormalities in laboratory parameters have been presented.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 3 3 3 0
Measure Type: Number
Unit of Measure: Participants
3 3 3
3.Primary Outcome
Title Part 1 and 2: Number of Participants With Clinically Significant Physical Findings
Hide Description This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Part 1 and 2: Plasma Concentrations of MT-3724
Hide Description Blood samples were collected for Pharmacokinetic (PK) analysis of MT-3724. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination.
Time Frame Days 1,3 and 12 of treatment cycle (Each cycle is of 28 days); Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least one dose of MT-3724 and have at least one post-baseline PK assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 3 3 3 0
Mean (Standard Deviation)
Unit of Measure: Micrograms per milliliter
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (>30 percent [%] of values were imputed)
5.Secondary Outcome
Title Part 1 and 2: Change From Baseline in B-cell Count
Hide Description Blood samples were collected for analysis of B-cell count. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline PD assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 3 3 3 0
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Mean and Standard Deviation could not be calculated as 100% of the data was below the limit of quantification at all time points.
6.Secondary Outcome
Title Part 1 and 2: Number of Participants With Anti-drug Antibody Titer When Treated With MT-3724
Hide Description Blood samples were collected for analysis of ADA titer. Data was not collected due to early termination of the trial.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline immunogenicity assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Part 1 and 2: Number of Participants With Neutralizing Antibody (NAb) Titers When Treated With MT-3724
Hide Description Blood samples were planed to be collected for analysis of neutralizing antibody (NAb) titers. Data was not collected due to early termination of the trial.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline immunogenicity assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Part 1 and 2: Number of Participants With Objective Response Rate (ORR)
Hide Description ORR was defined as CR or Partial Response (PR). CR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Higher score indicates worse outcomes.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial. The rows presenting data for PR and CR are mutually exclusive.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 3 3 3 0
Measure Type: Number
Unit of Measure: participants
PR 2 0 1
CR 1 2 1
9.Secondary Outcome
Title Part 1 and 2: Duration of Response (DOR)
Hide Description DOR is defined as the time from the first documented complete or partial response to the actual date of disease progression or death before progression. Data was not collected due to early termination of the trial.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Part 1 and 2: Progression Free Survival (PFS)
Hide Description PFS is defined as the time from first dose date until the first occurrence of documented disease progression or death from any cause in the absence of progressive disease. Data was not collected due to early termination of the trial.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Part 1 and 2: Overall Survival (OS)
Hide Description OS is defined as the time from date of start of treatment to date of death due to any cause. Data was not collected due to early termination of the trial.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description:
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Adverse Event Reporting Description Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
 
Arm/Group Title Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Hide Arm/Group Description Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle. Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
All-Cause Mortality
Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/0    
Hide Serious Adverse Events
Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/3 (33.33%)      1/3 (33.33%)      0/0    
Blood and lymphatic system disorders         
Neutropenia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0
Anaemia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0
Cardiac disorders         
Atrial fibrillation  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0
Congestive heart failure  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0
Infections and infestations         
Bacteraemia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0
Pneumonia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0
Vascular disorders         
Capillary leak syndrome  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1: MT-3724 10 mcg/Kg-LEN Part 1: MT-3724 25 mcg/Kg-LEN Part 1: MT-3724 20 mcg/Kg-LEN Part 2: MT-3724 50mcg/Kg-LEN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      0/0    
Blood and lymphatic system disorders         
Anaemia  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Leukopenia  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Neutropenia  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Thrombocytopenia  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Cardiac disorders         
Diastolic dysfunction  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Left atrial enlargement  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Eye disorders         
Vitreous floaters  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Gastrointestinal disorders         
Constipation  1  2/3 (66.67%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Diarrhoea  1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Nausea  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Abdominal distension  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Oral disorder  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Rectal haemorrhage  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
General disorders         
Fatigue  1  1/3 (33.33%)  2/3 (66.67%)  2/3 (66.67%)  0/0 
Oedema peripheral  1  0/3 (0.00%)  3/3 (100.00%)  1/3 (33.33%)  0/0 
Pyrexia  1  0/3 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  0/0 
Chest discomfort  1  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/0 
Non-cardiac chest pain  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Infections and infestations         
Cellulitis  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Rhinitis  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Upper respiratory tract infection  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Urinary tract infection  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Investigations         
Weight increased  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Aspartate aminotransferase increased  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Blood alkaline phosphatase increased  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Blood bilirubin increased  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Neutrophil count decreased  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Transaminase increased  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Weight decreased  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Metabolism and nutrition disorders         
Hypokalaemia  1  2/3 (66.67%)  1/3 (33.33%)  2/3 (66.67%)  0/0 
Hypoalbuminaemia  1  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/0 
Hyperglycaemia  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Hypocalcaemia  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Hypomagnesaemia  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Hypoproteinaemia  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/3 (0.00%)  3/3 (100.00%)  1/3 (33.33%)  0/0 
Muscular weakness  1  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  0/0 
Pain in extremity  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Arthralgia  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Back pain  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Musculoskeletal stiffness  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Pain in jaw  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Nervous system disorders         
Dizziness  1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Hypoaesthesia  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/0 
Peripheral sensory neuropathy  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Psychiatric disorders         
Insomnia  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Renal and urinary disorders         
Proteinuria  1  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Glycosuria  1  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Haematuria  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Cough  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Dysphonia  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Dyspnea  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
Skin and subcutaneous tissue disorders         
Rash  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Palmar-plantar erythrodysaesthesia syndrome  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/0 
Vascular disorders         
Capillary leak syndrome  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/0 
Hypotension  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/0 
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Molecular Templates, Inc.
Phone: 862-204-7184
EMail: trials@mtem.com
Layout table for additonal information
Responsible Party: Molecular Templates, Inc.
ClinicalTrials.gov Identifier: NCT03645395    
Other Study ID Numbers: MT-3724_NHL_003
First Submitted: July 19, 2018
First Posted: August 24, 2018
Results First Submitted: June 1, 2022
Results First Posted: August 16, 2022
Last Update Posted: August 16, 2022