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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06633042

Enrollment

Registered

2024-10-09

Start date

2024-11-25

Completion date

2025-12-12

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Disease

Keywords

Universal BCMA CART, AQP4 Antibody Positive, RefractoryNeuromyelitis Optica Spectrum Disease

Brief summary

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.

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).

Interventions

DRUGUniversal BCMA-CD19 CART

1.0-4.0×10\^6 CAR-T cells/kg

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
DLT	Within28 Days After BRL-302 Infusion	The number and severity of dose-limiting toxicity (DLT) events
AEs	Up to 12 Months After BRL-302 Infusion	The total number, incidence, and severity of AEs

Secondary

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

Contacts

Primary ContactXiaohui Wang, PhD

xiaoxiao512006@163.com18701533866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026