Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma
Study Details
Study Description
Brief Summary
This trial aims to evaluate the safety and efficacy of BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: BCMA-CART Autologous T cells transduced to express anti-BCMA chimeric antigen receptor (CAR) |
Biological: BCMA-CART
After a conditioning therapy, each patient will receive a treatment of BCMA-CART originated from their own peripheral blood mononuclear cells
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Shanghai Bioray Laboratories INC. | Shanghai | Shanghai | China | 200241 |
Sponsors and Collaborators
- Bioray Laboratories
- The First Affiliated Hospital of Zhengzhou University
- Second Xiangya Hospital of Central South University
Investigators
- Principal Investigator: Yunxiao Xu, MD, Second Xiangya Hospital of Central South University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-CART-00CH3(1)