Efficacy and Safety Evaluation of PD1-BCMA-CART

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05308875
• Other study ID #: 2021-BRL-202
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: July 2023
• Source: Bioray Laboratories
• Contact: wei Li, PhD
• Phone: +8618621670308
• Email: adamweili[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: October 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
China	First Affliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Bioray Laboratories	The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 90 days after T cell infusion
Secondary	Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability	Adverse events assessed according to NCI-CTCAE v5.0 criteria	Up to 35 days after T cell infusion
Secondary	Duration of persistence of PD1-BCMA-CART	Detect the duration of PD1-BCMA-CART after injection using FACS or Q-PCR	Baseline up to 2 year