Study of BCMA CAR-T in Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03559764|
Recruitment Status : Unknown
Verified June 2018 by Allife Medical Science and Technology Co., Ltd..
Recruitment status was: Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsed and Refractory Multiple Myeloma||Biological: Anti-BCMA CAR T cells||Early Phase 1|
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.CAR - T cells was taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain. The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.
In order to lay a foundation for the application of relapsed/refractory multiple myeloma patients with CAR-T therapy，objects are refractory/ relapsed patients with multiple myeloma,and plans to into the group of the number of cases in 20 cases.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Anti-BCMA CAR T cells
Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively).
Biological: Anti-BCMA CAR T cells
Transparent colorless or slightly yellow liquid
- The safety of CAR T is evaluated to determine if CRS occurred [ Time Frame: Day 3-Year 2 after injection ]defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment