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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2025-12-12

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Autoimmune Disease

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Total target count of CD3+CAR+ viable cells of 1E6/kg 、2E6/kg and 4E6/kg

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BCMA CART Group

1.0-4.0×10\^6 CAR- Tcells/kg

Group Type EXPERIMENTAL

Universal BCMA-CD19 CART

Intervention Type DRUG

1.0-4.0×10\^6 CAR-T cells/kg

Interventions

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Universal BCMA-CD19 CART

1.0-4.0×10\^6 CAR-T cells/kg

Intervention Type DRUG

Other Intervention Names

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BRL-302

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No