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

Safety and Efficacy Evaluation of Autologous BCMA-CART for Treating Relapsed or Refractory Multiple Myeloma

This trial aims to evaluate the safety and efficacy of BCMA-CART in treating patients with relapsed or refractory multiple myeloma.

Study Overview

• Status: Withdrawn
• Conditions: Multiple Myeloma
• Intervention / Treatment: Biological: BCMA-CART

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200241
      • Shanghai Bioray Laboratories Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	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.	Up to 90 days after T cell infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Adverse Events as a Measure of Safety	Adverse events assessed according to NCI-CTCAE v4.03 criteria	Baseline up to 35 days
Duration of persistence of BCMA-CART	BCMA-CART duration be assessed by FACS or QPCR	Baseline up to 1 year

Collaborators and Investigators

• Sponsor: Bioray Laboratories
• Collaborators: The First Affiliated Hospital of Zhengzhou University; Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 2018-CART-00CH3(1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No