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

NCT06633042 | Not Yet Recruiting Phase 1

• 1 other identifier: 2024-BRL-302-01
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autoimmune Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• DLT

  The number and severity of dose-limiting toxicity (DLT) events

  Within28 Days After BRL-302 Infusion

• AEs

  The total number, incidence, and severity of AEs

  Up to 12 Months After BRL-302 Infusion

Secondary Outcomes (1)

• Annualized relapse rate (ARR)

  1,3,6,12 month after BRL-302 infusion

Study Arms (1)

BCMA CART Group

EXPERIMENTAL

1.0-4.0×10\^6 CAR- Tcells/kg

Drug: Universal BCMA-CD19 CART

Interventions

Universal BCMA-CD19 CART DRUG

1.0-4.0×10\^6 CAR-T cells/kg

Also known as: BRL-302

BCMA CART Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioray Laboratories: lead
• Wenzhou Medical University Affiliated Ophthalmology Hospital: collaborator

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Xiaohui Wang, PhD

  Wenzhou Medical University Affiliated Ophthalmology Hospital

  STUDY CHAIR

Central Study Contacts

Xiaohui Wang, PhD

CONTACT

18701533866; xiaoxiao512006@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 9, 2024
• Study Start: November 25, 2024
• Primary Completion: October 12, 2025
• Study Completion: December 12, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share