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Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell

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: NCT03019055
Recruitment Status : Completed
First Posted : January 12, 2017
Results First Posted : May 7, 2021
Last Update Posted : July 14, 2022
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Nirav Shah, Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions Biological: CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)
Biological: CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)
Biological: CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)
Biological: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
Enrollment 26
Recruitment Details Of 31 enrolled subjects who signed the informed consent form, 26 met all eligibility criteria.
Pre-assignment Details  
Arm/Group Title CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Hide Arm/Group Description

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)

Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Period Title: Overall Study
Started 0 3 3 20
Completed 0 3 3 20
Not Completed 0 0 0 0
Arm/Group Title CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg) Total
Hide Arm/Group Description

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)

Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Total of all reporting groups
Overall Number of Baseline Participants 0 3 3 20 26
Hide Baseline Analysis Population Description
Due to a lack of dose limiting toxicities at higher dosages, no subjects were enrolled in the 1.0x10^5 cell/kg dosage level.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 3 participants 3 participants 20 participants 26 participants
52.33  (2.31) 55.00  (8.19) 55.85  (14.44) 55.35  (12.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 3 participants 3 participants 20 participants 26 participants
Female
1
  33.3%
0
   0.0%
3
  15.0%
4
  15.4%
Male
2
  66.7%
3
 100.0%
17
  85.0%
22
  84.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 3 participants 3 participants 20 participants 26 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
20
 100.0%
26
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 3 participants 3 participants 20 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   5.0%
1
   3.8%
Asian
1
  33.3%
0
   0.0%
1
   5.0%
2
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  10.0%
2
   7.7%
White
2
  66.7%
3
 100.0%
16
  80.0%
21
  80.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 3 participants 3 participants 20 participants 26 participants
3 3 20 26
1.Primary Outcome
Title Number of Adverse Events After CAR 20/19-T Cell Infusion
Hide Description This measure is the number of adverse events with grade 3 to 5 severity per Common Terminology Criteria for Adverse Events (ver. 4.03) occurring within the first 28 days following infusion.
Time Frame 28 days after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Of the eligible subjects, CAR cell product did not reach the required cell concentration for infusion for 4 subjects in the highest dosage level. These subjects were withdrawn by the investigator. Overall, 22 subjects received the investigational product in this study. The initial concentration for the study was 2.5x10^5 cells/kg. No dose limiting toxicities were experienced at this concentration and the reduced dose of 1.0x10^5 cells/kg was not used.
Arm/Group Title CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Hide Arm/Group Description:

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)

Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Overall Number of Participants Analyzed 0 3 3 16
Measure Type: Number
Unit of Measure: Serious Adverse Events
7 4 22
Time Frame 28 days
Adverse Event Reporting Description No subjects were enrolled in the 1.0x10^5 cells/kg dosage group.
 
Arm/Group Title CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Hide Arm/Group Description

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)

Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)

Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1 in the Phase 1 portion and as a single infusion in the Phase 1b portion.

CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg): CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

All-Cause Mortality
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0      0/3 (0.00%)      0/3 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      3/3 (100.00%)      3/3 (100.00%)      16/16 (100.00%)    
Blood and lymphatic system disorders         
Blood and lymphatic system disorders - Other, specify  1  0/0  0 1/3 (33.33%)  1 1/3 (33.33%)  1 2/16 (12.50%)  2
Febrile neutropenia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders         
Diarrhea  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
General disorders         
Fever  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Multi-organ failure  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Immune system disorders         
Cytokine release syndrome  1  0/0  0 3/3 (100.00%)  3 0/3 (0.00%)  0 2/16 (12.50%)  2
Infections and infestations         
Infections and infestations - Other, specify  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Upper respiratory infection  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/16 (0.00%)  0
Investigations         
Lymphocyte count increased  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Metabolism and nutrition disorders         
Anorexia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  2
Dehydration  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/16 (18.75%)  3
Nervous system disorders         
Nervous system disorders - Other, specify  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/16 (0.00%)  0
Psychiatric disorders         
Psychiatric disorders - Other, specify  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/16 (12.50%)  3
Renal and urinary disorders         
Hematuria  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  3
Respiratory, thoracic and mediastinal disorders         
Pleural effusion  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Pneumonitis  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/16 (0.00%)  0
1
Term from vocabulary, MedDRA (12.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (7.5 x10^5 CAR-20/19-T Cells/kg) CAR-20/19-T Cells (2.5 x10^6 CAR-20/19-T Cells/kg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      3/3 (100.00%)      3/3 (100.00%)      16/16 (100.00%)    
Blood and lymphatic system disorders         
Anemia  1  0/0  0 3/3 (100.00%)  13 2/3 (66.67%)  12 14/16 (87.50%)  37
Blood and lymphatic system disorders - Other, specify  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Disseminated intravascular coagulation  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 2/16 (12.50%)  2
Febrile neutropenia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Leukocytosis  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  3
Cardiac disorders         
Atrial fibrillation  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Sinus bradycardia  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/16 (18.75%)  3
Sinus tachycardia  1  0/0  0 0/3 (0.00%)  0 2/3 (66.67%)  3 10/16 (62.50%)  15
Ear and labyrinth disorders         
Ear pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Tinnitus  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  2
Eye disorders         
Blurred vision  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Dry eye  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Eye pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Floaters  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 1/16 (6.25%)  1
Watering eyes  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  2
Gastrointestinal disorders         
Abdominal distension  1  0/0  0 1/3 (33.33%)  2 0/3 (0.00%)  0 2/16 (12.50%)  2
Abdominal pain  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/16 (12.50%)  2
Bloating  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  3
Constipation  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  8 6/16 (37.50%)  9
Diarrhea  1  0/0  0 2/3 (66.67%)  4 0/3 (0.00%)  0 11/16 (68.75%)  18
Dyspepsia  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Dysphagia  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/16 (12.50%)  3
Fecal incontinence  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Gingival pain  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Nausea  1  0/0  0 1/3 (33.33%)  2 1/3 (33.33%)  6 11/16 (68.75%)  17
Stomach pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/16 (18.75%)  5
Toothache  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Vomiting  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  4 3/16 (18.75%)  4
Gastroesophageal reflux disease  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/16 (6.25%)  1
General disorders         
Chills  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Facial pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Fatigue  1  0/0  0 2/3 (66.67%)  3 3/3 (100.00%)  7 12/16 (75.00%)  20
Fever  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/16 (25.00%)  6
Flu like symptoms  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Malaise  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Multi-organ failure  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Edema limbs  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/16 (25.00%)  4
Infusion related reaction  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Non-cardiac chest pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  2
Infusion site extravasation  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Immune system disorders         
Cytokine release syndrome  1  0/0  0 1/3 (33.33%)  1 1/3 (33.33%)  4 13/16 (81.25%)  18
Infections and infestations         
Infections and infestations - Other, specify  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  1 3/16 (18.75%)  4
Sepsis  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Upper respiratory infection  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Urinary tract infection  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/16 (18.75%)  3
Enterocolitis infectious  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Lung infection  1  0/0  0 1/3 (33.33%)  2 0/3 (0.00%)  0 3/16 (18.75%)  3
Injury, poisoning and procedural complications         
Fracture  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Vascular access complication  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/16 (18.75%)  4
Investigations         
Activated partial thromboplastin time prolonged  1  0/0  0 1/3 (33.33%)  1 1/3 (33.33%)  1 6/16 (37.50%)  7
Alanine aminotransferase increased  1  0/0  0 2/3 (66.67%)  2 0/3 (0.00%)  0 7/16 (43.75%)  10
Alkaline phosphatase increased  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 6/16 (37.50%)  10
Aspartate aminotransferase increased  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 9/16 (56.25%)  17
Blood bilirubin increased  1  0/0  0 1/3 (33.33%)  3 1/3 (33.33%)  2 3/16 (18.75%)  6
Creatinine increased  1  0/0  0 2/3 (66.67%)  7 0/3 (0.00%)  0 8/16 (50.00%)  14
Fibrinogen decreased  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Lymphocyte count decreased  1  0/0  0 2/3 (66.67%)  8 3/3 (100.00%)  15 16/16 (100.00%)  49
Lymphocyte count increased  1  0/0  0 1/3 (33.33%)  4 0/3 (0.00%)  0 1/16 (6.25%)  1
Neutrophil count decreased  1  0/0  0 3/3 (100.00%)  12 3/3 (100.00%)  21 16/16 (100.00%)  59
Platelet count decreased  1  0/0  0 2/3 (66.67%)  12 2/3 (66.67%)  11 13/16 (81.25%)  32
Weight loss  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
White blood cell decreased  1  0/0  0 3/3 (100.00%)  9 3/3 (100.00%)  13 16/16 (100.00%)  68
Metabolism and nutrition disorders         
Anorexia  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 4/16 (25.00%)  5
Hypercalcemia  1  0/0  0 2/3 (66.67%)  8 0/3 (0.00%)  0 2/16 (12.50%)  3
Hyperglycemia  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  6 9/16 (56.25%)  14
Hyperkalemia  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 2/16 (12.50%)  2
Hypermagnesemia  1  0/0  0 1/3 (33.33%)  1 1/3 (33.33%)  2 1/16 (6.25%)  1
Hypernatremia  1  0/0  0 1/3 (33.33%)  2 0/3 (0.00%)  0 3/16 (18.75%)  7
Hypertriglyceridemia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Hyperuricemia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  3
Hypoalbuminemia  1  0/0  0 3/3 (100.00%)  11 1/3 (33.33%)  1 10/16 (62.50%)  27
Hypocalcemia  1  0/0  0 2/3 (66.67%)  6 1/3 (33.33%)  6 13/16 (81.25%)  27
Hypoglycemia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Hypokalemia  1  0/0  0 2/3 (66.67%)  5 0/3 (0.00%)  0 7/16 (43.75%)  16
Hypomagnesemia  1  0/0  0 1/3 (33.33%)  2 0/3 (0.00%)  0 2/16 (12.50%)  7
Hyponatremia  1  0/0  0 1/3 (33.33%)  8 1/3 (33.33%)  2 9/16 (56.25%)  21
Hypophosphatemia  1  0/0  0 1/3 (33.33%)  4 1/3 (33.33%)  2 4/16 (25.00%)  6
Tumor lysis syndrome  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  1 3/16 (18.75%)  3
Back pain  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 1/16 (6.25%)  1
Flank pain  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/16 (12.50%)  2
Myalgia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  2
Neck pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Pain in extremity  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Generalized muscle weakness  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Nervous system disorders         
Dizziness  1  0/0  0 1/3 (33.33%)  1 1/3 (33.33%)  1 6/16 (37.50%)  10
Dysphasia  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Headache  1  0/0  0 2/3 (66.67%)  3 1/3 (33.33%)  1 8/16 (50.00%)  11
Lethargy  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Movements involuntary  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Paresthesia  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/16 (0.00%)  0
Peripheral sensory neuropathy  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Presyncope  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Somnolence  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Syncope  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Tremor  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Vasovagal reaction  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Facial muscle weakness  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Psychiatric disorders         
Agitation  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 1/16 (6.25%)  1
Anxiety  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/16 (12.50%)  2
Confusion  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/16 (18.75%)  4
Delirium  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/16 (18.75%)  4
Hallucinations  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Insomnia  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/16 (0.00%)  0
Psychiatric disorders - Other, specify  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 4/16 (25.00%)  5
Renal and urinary disorders         
Hematuria  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/16 (18.75%)  4
Proteinuria  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Urinary frequency  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Urinary incontinence  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/16 (18.75%)  3
Urinary retention  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Urinary tract pain  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Acute kidney injury  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/16 (18.75%)  3
Reproductive system and breast disorders         
Genital edema  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/16 (6.25%)  1
Apnea  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Aspiration  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Atelectasis  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Cough  1  0/0  0 1/3 (33.33%)  2 1/3 (33.33%)  1 5/16 (31.25%)  7
Dyspnea  1  0/0  0 1/3 (33.33%)  2 0/3 (0.00%)  0 2/16 (12.50%)  2
Hypoxia  1  0/0  0 2/3 (66.67%)  3 0/3 (0.00%)  0 4/16 (25.00%)  6
Pleural effusion  1  0/0  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/16 (0.00%)  0
Productive cough  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 1/16 (6.25%)  1
Respiratory failure  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Sore throat  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/16 (25.00%)  5
Wheezing  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/16 (12.50%)  2
Pruritus  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  2
Rash maculo-papular  1  0/0  0 0/3 (0.00%)  0 1/3 (33.33%)  2 2/16 (12.50%)  2
Skin and subcutaneous tissue disorders - Other, specify  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
Surgical and medical procedures         
Surgical and medical procedures - Other, specify  1  0/0  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/16 (0.00%)  0
Vascular disorders         
Hypertension  1  0/0  0 2/3 (66.67%)  8 3/3 (100.00%)  9 8/16 (50.00%)  13
Hypotension  1  0/0  0 0/3 (0.00%)  0 2/3 (66.67%)  3 7/16 (43.75%)  15
Thromboembolic event  1  0/0  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/16 (6.25%)  1
1
Term from vocabulary, MedDRA (12.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nirav Shah, MD
Organization: Froedtert Hospital and the Medical College of Wisconsin
Phone: 414-805-8900
EMail: cccto@mcw.edu
Layout table for additonal information
Responsible Party: Nirav Shah, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03019055    
Other Study ID Numbers: PRO00028724
First Submitted: January 5, 2017
First Posted: January 12, 2017
Results First Submitted: April 12, 2021
Results First Posted: May 7, 2021
Last Update Posted: July 14, 2022