Clinical trial NCT03492268: Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma
Official title: Safety and Efficacy Evaluation of Autologous BCMA-CART for Treating Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Bioray Laboratories
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Second Xiangya Hospital of Central South University
First posted: 2018-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 90 days after T cell infusion
Secondary outcomes:
measure: Incidence and Severity of Adverse Events as a Measure of Safety
timeFrame: Baseline up to 35 days
measure: Duration of persistence of BCMA-CART
timeFrame: Baseline up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Bioray Laboratories INC.
state: Shanghai
Study officials:
affiliation: Second Xiangya Hospital of Central South University
name: Yunxiao Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: