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

NCT03492268 | Withdrawn

• 1 other identifier: 2018-CART-00CH3(1)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence and Severity of Adverse Events as a Measure of Safety

  Baseline up to 35 days

• Duration of persistence of BCMA-CART

  Baseline up to 1 year

Study Arms (1)

BCMA-CART

EXPERIMENTAL

Autologous T cells transduced to express anti-BCMA chimeric antigen receptor (CAR)

Biological: BCMA-CART

Interventions

BCMA-CART BIOLOGICAL

After a conditioning therapy, each patient will receive a treatment of BCMA-CART originated from their own peripheral blood mononuclear cells

BCMA-CART

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioray Laboratories: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Shanghai Bioray Laboratories INC.

Shanghai, Shanghai Municipality, 200241, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yunxiao Xu, MD

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: November 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)