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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03492268
• Other study ID #: 2018-CART-00CH3(1)
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: Bioray Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Bioray Laboratories INC.	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Bioray Laboratories	Second Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of persistence of BCMA-CART	BCMA-CART duration be assessed by FACS or QPCR	Baseline up to 1 year