Multiple Myeloma
Conditions
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.
Interventions
BIOLOGICALBCMA-CART
After a conditioning therapy, each patient will receive a treatment of BCMA-CART originated from their own peripheral blood mononuclear cells
Sponsors
The First Affiliated Hospital of Zhengzhou University
Second Xiangya Hospital of Central South University
Bioray Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients undergo leukapheresis to separate their lymphocytes, from which CART cells are produced. Patients will receive a conditioning therapy with cyclophosphamide and fludarabine before CART therapy. BCMA-CART cells will be injected intravenously (IV) into patients on day 0.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed