Status:
RECRUITING
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases
Lead Sponsor:
Tianjin Huanhu Hospital
Collaborating Sponsors:
Shanghai Xiniao Biotech Co., Ltd.
Conditions:
Neuromyelitis Optica Spectrum Disorders
Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of ...
Detailed Description
This is an investigator-initiated trial to evaluate the safety and efficacy of universal CD19/BCMA CAR T-cells in Relapsed or Refractory Neurological Autoimmune Diseases. Study intervention consists ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
- Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).
- Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
- Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion
- Subjects with a history of severe drug allergies or allergic tendencies.
- History of malignancy within five years.
- Subjects with insufficient cardiac function.
- Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.
- Pregnant women or women planning to conceive.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06939166
Start Date
June 17 2025
End Date
October 1 2027
Last Update
December 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tianjin Huanhu Hospital
Tianjin, China