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Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas (CIVIC)

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: NCT02763254
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : May 5, 2016
Results First Posted : March 12, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Cell Medica Ltd

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hodgkin Lymphoma
Lymphoma, Large B-Cell, Diffuse
Post-transplant Lymphoproliferative Disorder
Intervention Biological: baltaleucel-T
Enrollment 1
Recruitment Details Study was closed early due to inadequate recruitment.
Pre-assignment Details  
Arm/Group Title Baltaleucel-T
Hide Arm/Group Description

Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

baltaleucel-T: Autologous EBV-specific T cells

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Baltaleucel-T
Hide Arm/Group Description

Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

baltaleucel-T: Autologous EBV-specific T cells

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
Cohort B - Hodgkin Lymphoma (HL)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
1
 100.0%
[1]
Measure Description: Relapse or refractory HL disease post brentuximab vedotin (BV) or unable to tolerate BV.
1.Primary Outcome
Title Best Overall Response
Hide Description Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Subject was withdrawn early before first disease assessment timepoint.
Arm/Group Title Balteleucel-T
Hide Arm/Group Description:

Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

balteleucel-T: Autologous EBV-specific T cells

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Adverse Events
Hide Description Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Balteleucel-T
Hide Arm/Group Description:

Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

balteleucel-T: Autologous EBV-specific T cells

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame 1 month
Adverse Event Reporting Description Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious.
 
Arm/Group Title Baltaleucel-T
Hide Arm/Group Description

Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.

baltaleucel-T: Autologous EBV-specific T cells

All-Cause Mortality
Baltaleucel-T
Affected / at Risk (%)
Total   1/1 (100.00%)    
Hide Serious Adverse Events
Baltaleucel-T
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Hemophagocytic Lymphohistiosytosis   1/1 (100.00%)  1
Immune system disorders   
Cytokine Release Syndrome   1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Baltaleucel-T
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Anemia  [1]  1/1 (100.00%)  2
General disorders   
Fatigue  [2]  1/1 (100.00%)  1
Investigations   
Platelet Count Decreased  [3]  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
[1]
Grade 3
[2]
Grade 1
[3]
Grade 4
Early termination leading to small numbers of subjects analyzed.
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: Dr. Kurt Gunter (Chief Medical Officer)
Organization: Cell Medica
Phone: 832-581-4480
EMail: Kurt.Gunter@cellmedica.com
Layout table for additonal information
Responsible Party: Cell Medica Ltd
ClinicalTrials.gov Identifier: NCT02763254    
Other Study ID Numbers: CM-2015-01
First Submitted: April 27, 2016
First Posted: May 5, 2016
Results First Submitted: February 19, 2019
Results First Posted: March 12, 2019
Last Update Posted: March 26, 2019