Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma

Not Applicable

Withdrawn

• Conditions: Multiple Myeloma
• Interventions: Biological: BCMA-CART

• 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.

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Study Start: 2021-11-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-17
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCMA-CART	BCMA-CART	Autologous T cells transduced to express anti-BCMA chimeric antigen receptor (CAR)

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