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Efficacy and Safety Evaluation of BCMA-UCART

Primary Purpose

Multiple Myeloma

Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BCMA-UCART
Sponsored by
Bioray Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

  • Subjects according with any of the following options:

    • Age≥50;
    • Failure with separation of T cells during autologous CART processing; or,
    • Failure with expansion of autologous CART; or,
    • The proportion of T cells in PBMC <10%; or,
    • Won't benefit from autologous CART therapy because of disease progress.

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 Tongji Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BCMA-UCART

Arm Description

Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW.

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 and Tolerability
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Duration of persistence of BCMA-UCART
Detect the duration of BCMA-UCART after injection using FACS or Q-PCR

Full Information

First Posted
November 21, 2018
Last Updated
May 15, 2022
Sponsor
Bioray Laboratories
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine, Second Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03752541
Brief Title
Efficacy and Safety Evaluation of BCMA-UCART
Official Title
Efficacy and Safety Evaluation of BCMA-UCART（Allogeneic Engineered T-cells Expressing Anti-BCMA Chimeric Antigen Receptor）in the Treatment of Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Why Stopped
decided by the sponsor
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
March 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioray Laboratories
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine, 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

5. Study Description

Brief Summary
This trial aims to evaluate the safety and efficacy of BCMA-UCART 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 T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a kind of allogeneic CART, originating from T cells of health donors. This open-label, dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in treating relapsed or 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
Sequential Assignment
Model Description
0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCMA-UCART
Arm Type
Experimental
Arm Description
Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1*10~6/KgBW, 1-2*10~6/KgBW,2-3*10~6/KgBW.
Intervention Type
Biological
Intervention Name(s)
BCMA-UCART
Intervention Description
A conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy.
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 and Tolerability
Description
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Time Frame
Up to 35 days after T cell infusion
Title
Duration of persistence of BCMA-UCART
Description
Detect the duration of BCMA-UCART after injection using FACS or Q-PCR
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
Accepts Healthy Volunteers
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. Subjects according with any of the following options: Age≥50; Failure with separation of T cells during autologous CART processing; or, Failure with expansion of autologous CART; or, The proportion of T cells in PBMC <10%; or, Won't benefit from autologous CART therapy because of disease progress. 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
Aibin Liang, PhD
Organizational Affiliation
Shanghai Tongji Hospital, Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety Evaluation of BCMA-UCART

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