A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 Treatment in DLBCL Subjects (C-CAR011)
|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: NCT02976857|
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Refractory Diffuse Large B-Cell Lymphoma||Biological: C-CAR-011||Phase 1|
The 3x3 dose escalation design will be adopted in order to determine the maximum tolerated dose (MTD). Subjects will be enrolled into low-dose group, medium-dose group and high-dose group as below:
Dose CAR+ cells/kg
DLT is evaluated within 30 days post C-CAR011 infusion).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Single Center, Non-randomized Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Refractory Diffuse Large B-cell Lymphoma|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||September 11, 2018|
|Actual Study Completion Date :||January 9, 2019|
C-CAR011 infusion In the first cell therapy 0, 1 and 2 days, respectively 10%, 30% and 60% ratio three times reinfusion.
lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene.
Other Name: CAR-CD19
- Dose-limiting toxicity (DLT) [ Time Frame: 28 days ]Non-haematological dose-limiting toxicities was any toxicity of grade 3 or higher occurring within 28 days of C-CAR011 infusion judged possibly related to the treatment regimen.The following toxicities were not considered dose limiting toxicities: tumor lysis syndrome, abnormal electrolytes responding to supplementation, hypoalbuminemia, liver dysfunction resolving to ≤grade 2 within 14 days, transient (<72 hours) grade 4 hepatic enzyme abnormality, and grade 3 or 4 fever or neutropenic fever.
- Overall response rate [ Time Frame: 4 and 12 weeks ]Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 4 and weeks 12 according to International Working Group (IWG) revised criteria.
- Disease control rate [ Time Frame: 12 weeks ]Disease control rate (DCR） = complete response (CR) rate + partial response (PR) rate + stable disease (SD) rate, DCR will be assessed at weeks 12 according to International Working Group (IWG) revised criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976857
|Hematological Department, People's Hospital of Jiangsu Province|
|Nanjing City, Jiangsu, China, 210029|
|Principal Investigator:||Jianyong Li||The First Affiliated Hospital with Nanjing Medical University|