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

Bioray Laboratories

Status and phase

Not yet enrolling

Phase 1

Conditions

Autoimmune Disease

Treatments

Drug: Universal BCMA-CD19 CART

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06633042

2024-BRL-302-01

Details and patient eligibility

About

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.

Full 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).

Enrollment

18 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.