Back to resultsSafety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BCMA-CART
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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.
Sites / Locations
- Shanghai Bioray Laboratories INC.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BCMA-CART
Arm Description
Autologous T cells transduced to express anti-BCMA chimeric antigen receptor (CAR)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence and Severity of Adverse Events as a Measure of Safety
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Duration of persistence of BCMA-CART
BCMA-CART duration be assessed by FACS or QPCR
Full Information
NCT ID
NCT03492268
First Posted
April 3, 2018
Last Updated
May 15, 2022
Sponsor
Bioray Laboratories
Collaborators
The First Affiliated Hospital of Zhengzhou University, Second Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03492268
Brief Title
Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma
Official Title
Safety and Efficacy Evaluation of Autologous BCMA-CART for Treating Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Due to CART processing facility construction
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioray Laboratories
Collaborators
The First Affiliated Hospital of Zhengzhou University, Second Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCMA-CART
Arm Type
Experimental
Arm Description
Autologous T cells transduced to express anti-BCMA chimeric antigen receptor (CAR)
Intervention Type
Biological
Intervention Name(s)
BCMA-CART
Intervention Description
After a conditioning therapy, each patient will receive a treatment of BCMA-CART originated from their own peripheral blood mononuclear cells
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
Up to 90 days after T cell infusion
Secondary Outcome Measure Information:
Title
Incidence and Severity of Adverse Events as a Measure of Safety
Description
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Time Frame
Baseline up to 35 days
Title
Duration of persistence of BCMA-CART
Description
BCMA-CART duration be assessed by FACS or QPCR
Time Frame
Baseline up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunxiao Xu, MD
Organizational Affiliation
Second Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Bioray Laboratories INC.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200241
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma
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