RecruitingRecruiting
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
NCT06939166 · Tianjin Huanhu Hospital
In plain English
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Official title
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Neurological Autoimmune Diseases
About this study
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 of a single infusion of universal CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Interim analysis will be performed when participants finish the visit 90 days after CAR T-cell infusion.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Study design
Enrollment target: 12 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-17
Estimated completion: 2027-10
Last updated: 2025-12-15
Interventions
Drug: UCAR T-cell
Primary outcomes
- • The number and severity of dose-limiting toxicity (DLT) events (Within 28 Days After UCAR T-cell Infusion)
- • The total number, incidence, and severity of AEs (Up to 90 days After UCAR T-cell Infusion)
Sponsor
Tianjin Huanhu Hospital · other
With: Shanghai Xiniao Biotech Co., Ltd.
Contacts & investigators
ContactJialing Wu · contact · wywjl2009@hotmail.com · 86-18622271026
ContactGuanen Zhou · contact · tjzge@163.com · 86-13920273016
All locations (1)
Tianjin Huanhu HospitalRecruiting
Tianjin, China