Efficacy and Safety Evaluation of BCMA-UCART

Not Applicable

Suspended

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

• Registration Number: NCT03752541
• Lead Sponsor: Bioray Laboratories

Brief Summary

This trial aims to evaluate the safety and efficacy of BCMA-UCART 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 T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a kind of allogeneic CART, originating from T cells of health donors. This open-label, dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in treating relapsed or refractory multiple myeloma.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Study Start: 2019-11-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-20
• Primary Completion: 2023-03-20
• Study Completion: 2023-11-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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.

• Subjects according with any of the following options:

  • Age≥50;
  • Failure with separation of T cells during autologous CART processing; or,
  • Failure with expansion of autologous CART; or,
  • The proportion of T cells in PBMC <10%; or,
  • Won't benefit from autologous CART therapy because of disease progress.

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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BCMA-UCART	BCMA-UCART	Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1\*10\~6/KgBW, 1-2\*10\~6/KgBW,2-3\*10\~6/KgBW.

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 and Tolerability	Up to 35 days after T cell infusion	Adverse events assessed according to NCI-CTCAE v4.03 criteria
Duration of persistence of BCMA-UCART	Baseline up to 1 year	Detect the duration of BCMA-UCART after injection using FACS or Q-PCR

Trial Locations

Locations (1)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China