The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD

October 7, 2024 updated by: Bioray Laboratories

The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disease

This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-65 years ; both genders eligible.
  • Meets the criteria for Refractory NMOSD.
  • Anticipated survival of ≥ 12 weeks as judged by the researcher.
  • Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
  • Provides written informed consent.

Exclusion Criteria:

  • History of solid organ transplantation.
  • Malignant tumor within the last two years.
  • Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
  • Primary immunodeficiency (congenital or acquired).
  • Severe cardiac disease.
  • History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
  • Allergic constitution or a history of severe allergies.
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCMA CART Group
1.0-4.0×10^6 CAR- Tcells/kg
Drug: Universal BCMA-CD19 CART
1.0-4.0×10^6 CAR-T cells/kg
Other Names:
  • BRL-302

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: Within 28 Days After BRL-302 Infusion
The number and severity of dose-limiting toxicity (DLT) events
Within 28 Days After BRL-302 Infusion
AEs
Time Frame: Up to 12 Months After BRL-302 Infusion
The total number, incidence, and severity of AEs
Up to 12 Months After BRL-302 Infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized relapse rate (ARR)
Time Frame: 1,3,6,12 month after BRL-302 infusion
Number of NMOSD relapses in subjects after cell infusion divided by observation time (years)
1,3,6,12 month after BRL-302 infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioray Laboratories

Collaborators

Wenzhou Medical University Affiliated Ophthalmology Hospital

Investigators

  • Study Chair: Xiaohui Wang, PhD, Wenzhou Medical University Affiliated Ophthalmology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 12, 2024

Primary Completion (Estimated)

October 12, 2025

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-BRL-302-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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