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

Sponsor
Bioray Laboratories (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03492268
Collaborator
The First Affiliated Hospital of Zhengzhou University (Other), Second Xiangya Hospital of Central South University (Other)
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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
  • Biological: BCMA-CART
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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy Evaluation of Autologous BCMA-CART for Treating Relapsed or Refractory Multiple Myeloma
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

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

  1. 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

  1. 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

  2. Duration of persistence of BCMA-CART [Baseline up to 1 year]

    BCMA-CART duration be assessed by FACS or QPCR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

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.
Responsible Party:
Bioray Laboratories
ClinicalTrials.gov Identifier:
NCT03492268
Other Study ID Numbers:
  • 2018-CART-00CH3(1)
First Posted:
Apr 10, 2018
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022