Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT03492268
- Lead Sponsor
- Bioray Laboratories
- Brief Summary
This trial aims to evaluate the safety and efficacy of BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
- Detailed Description
BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma . Using a genetic engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in autologous T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. This trial aims to evaluate the safety and anti-tumor efficacy of autologous BCMA-CART in treating relapsed or treatment refractory multiple myeloma.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Have the capacity to give informed consent;
- Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
- Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
- Refractory and relapsed MM patients after > 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
- ECOG score=0-2.
- Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy;
- Active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B, hepatitis C at the time of screening;
- Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)> 5 x upper limit of normal; bilirubin > 3.0 mg/dL;
- Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis serious mental disorder;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
- Contraindication to cyclophosphamide or fludarabine chemotherapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Up to 90 days after T cell infusion Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
- Secondary Outcome Measures
Name Time Method Incidence and Severity of Adverse Events as a Measure of Safety Baseline up to 35 days Adverse events assessed according to NCI-CTCAE v4.03 criteria
Duration of persistence of BCMA-CART Baseline up to 1 year BCMA-CART duration be assessed by FACS or QPCR
Trial Locations
- Locations (1)
Shanghai Bioray Laboratories INC.
🇨🇳Shanghai, Shanghai, China
Shanghai Bioray Laboratories INC.🇨🇳Shanghai, Shanghai, China