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Efficacy and Safety Evaluation of PD1-BCMA-CART

Primary Purpose

Multiple Myeloma

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PD1-BCMA-CART

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

First Affliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD1-BCMA-CART

Arm Description

Each subject will accept one of the following dosages of PD1-BCMA-CART cells intravenously (IV) on day 0: 0.5-2*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 v5.0 criteria

Duration of persistence of PD1-BCMA-CART

Detect the duration of PD1-BCMA-CART after injection using FACS or Q-PCR

Full Information

NCT ID

NCT05308875

First Posted

January 27, 2022

Last Updated

July 21, 2023

Sponsor

Bioray Laboratories

Collaborators

The First Affiliated Hospital of Zhengzhou University

1. Study Identification

Unique Protocol Identification Number

NCT05308875

Brief Title

Efficacy and Safety Evaluation of PD1-BCMA-CART

Official Title

Clinical Study of the Safety and Efficacy of Non-viral Site-directed Integrated PD1-BCMA-CART in Adult Treatment of Relapsed or Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2023 (Anticipated)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioray Laboratories

Collaborators

The First Affiliated Hospital of Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.

Detailed Description

Using gene editing, chimeric antigen receptors recognizing BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back into the subjects could identify and kill myeloma cells in the subjects.This open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of PD1-BCMA-CART in the treatment of 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

0.5-2×10^6/kgBW

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD1-BCMA-CART

Arm Type

Experimental

Arm Description

Each subject will accept one of the following dosages of PD1-BCMA-CART cells intravenously (IV) on day 0: 0.5-2*10^6/KgBW.

Intervention Type

Biological

Intervention Name(s)

PD1-BCMA-CART

Intervention Description

Single infusion of PD1-BCMA-CART administered intravenously (i.v.)

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 v5.0 criteria

Time Frame

Up to 35 days after T cell infusion

Title

Duration of persistence of PD1-BCMA-CART

Description

Detect the duration of PD1-BCMA-CART after injection using FACS or Q-PCR

Time Frame

Baseline up to 2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wei Li, PhD

Phone

+8618621670308

adamweili@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Zhang, Professor

Organizational Affiliation

First Affliated Hospital of Zhengzhou University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety Evaluation of PD1-BCMA-CART

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