A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04322292|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: C-CAR088||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||September 12, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||November 2021|
Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene.
Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg.
Divided into three dose ranges of low(1.0-3.0×10^6 CAR+T cells/kg),medium(3.0-6.0×10^6 CAR+T cells/kg) and high(6.0-9.0×10^6 CAR+T cells/kg).
Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.
- Safety: The incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 30 days ]The incidence of treatment-emergent adverse events (TEAEs)
- Overall response rate (ORR) [ Time Frame: 12 months ]ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)
- Progression free survival (PFS) [ Time Frame: 6 months、12 months ]PFS(based on IMWG 2016 efficacy evaluation criteria)
- The CART cell duration in vivo [ Time Frame: 12 months ]The copys of BCMA-CART DNA in peripheral blood with qPCR method
- The soluble BCMA changes in peripheral blood [ Time Frame: 12 months ]The amount of soluble BCMA in peripheral blood with ELISA method
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): NCT04322292
|Contact: Gang An, PhD&MDfirstname.lastname@example.org|
|TianJin, China, 300000|
|Contact: Gang An, PhD&MD +008613502181109 email@example.com|