Efficacy and Safety Evaluation of PD1-BCMA-CART

Not Applicable

Not yet recruiting

• Conditions: Multiple Myeloma
• Interventions: Biological: PD1-BCMA-CART

• Registration Number: NCT05308875
• Lead Sponsor: Bioray Laboratories

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.

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Status Verified: 2023-07
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Study Start: 2024-03-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PD1-BCMA-CART	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

First Affliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China