Not yet recruitingNCT06633042Updated Nov 12, 2024

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

A Phase 1 interventional study of Universal BCMA-CD19 CART in Autoimmune Disease, sponsored by Bioray Laboratories. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Bioray Laboratories · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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).

Conditions studied

Autoimmune Disease

Browse trials for

Autoimmune Diseases 655

Keywords

Universal BCMA CART
AQP4 Antibody Positive
RefractoryNeuromyelitis Optica Spectrum Disease

In context

Autoimmune Diseases

655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.

This study's planned enrollment of 18 is below the median of 40 across 427 interventional studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

Bioray Laboratories is the lead sponsor of 24 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 18 participants (estimated)

Study arms

Experimental
BCMA CART Group
1.0-4.0×10\^6 CAR- Tcells/kg
Drug: Universal BCMA-CD19 CART

Interventions

DrugUniversal BCMA-CD19 CART
1.0-4.0×10\^6 CAR-T cells/kg
Also known as: BRL-302

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06633042
Lead sponsor: Bioray Laboratories
Collaborators: Wenzhou Medical University Affiliated Ophthalmology Hospital
Responsible party: Sponsor
First posted: Oct 9, 2024
Start date: Nov 25, 2024 (estimated)
Primary completion: Oct 12, 2025 (estimated)
Completion: Dec 12, 2025 (estimated)
Last update: Nov 12, 2024

Study contacts

Xiaohui Wang, PhD

Contact

xiaoxiao512006@163.com

18701533866

Xiaohui Wang, PhD

study chair · Wenzhou Medical University Affiliated Ophthalmology Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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