Efficacy and Safety Evaluation of PD1-BCMA-CART

NCT ID: NCT05308875

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-10-01

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PD1-BCMA-CART

Intervention Type: BIOLOGICAL

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

Interventions

PD1-BCMA-CART

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Bioray Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

First Affliated Hospital of Zhengzhou University

Locations

First Affliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Countries

China

Central Contacts

wei Li, PhD

Role: CONTACT

adamweili@126.com

+8618621670308

Other Identifiers

2021-BRL-202

Identifier Type: -

Identifier Source: org_study_id