CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients
|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: NCT04260945|
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : March 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|B-cell Leukemia||Biological: CD19/CD20 Dual-CAR-T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD19/CD20 Dual-CAR-T for Patients With B-cell Leukemia|
|Actual Study Start Date :||March 10, 2020|
|Actual Primary Completion Date :||October 10, 2021|
|Actual Study Completion Date :||February 10, 2022|
Experimental: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Biological: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 0.6-3×106 cells/kg.
- Percentage of participants with adverse events. [ Time Frame: 6 months ]
- Objective remission rate(ORR) [ Time Frame: 6 months ]The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
- Relapse-Free Survival(RFS ) [ Time Frame: 6 months ]
- Overall-Survival(OS) [ Time Frame: 6 months ]
- Persistence of CAR-T cells in vivo [ Time Frame: 6 months ]
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): NCT04260945
|Hebei Yanda Ludaopei Hospital|
|Sanhe, Hebei, China, 065200|