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Efficacy and Safety Evaluation of PD1-BCMA-CART

Sponsor
Bioray Laboratories (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05308875
Collaborator
The First Affiliated Hospital of Zhengzhou University (Other)
9
Enrollment
1
Location
1
Arm
30
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PD1-BCMA-CART
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
0.5-2×10^6/kgBW0.5-2×10^6/kgBW
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: PD1-BCMA-CART

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.

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

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [Up to 90 days after T cell infusion]

    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

  1. Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability [Up to 35 days after T cell infusion]

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

  2. Duration of persistence of PD1-BCMA-CART [Baseline up to 2 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affliated Hospital of Zhengzhou University Zhengzhou Henan China 450052

Sponsors and Collaborators

  • Bioray Laboratories
  • The First Affiliated Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Yi Zhang, Professor, First Affliated Hospital of Zhengzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bioray Laboratories
ClinicalTrials.gov Identifier:
NCT05308875
Other Study ID Numbers:
  • 2021-BRL-202
First Posted:
Apr 4, 2022
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of May 20, 2022