CAR-T Therapy for Refractory Autoimmune Diseases
- Sponsor
- LiangZou
- Study ID
- NCT07059169
- Status
- Recruiting
Conditions
- Autoimmune Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- JY231 (JY231 injection) — DRUGJY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion.
Study Details
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases.
Key Dates
- First listed
- Jul 10, 2025
- Start date
- Aug 4, 2025
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CD19 CAR-T for the treatment of refractory autoimmune diseasesCD19 CAR-T for the Treatment of refractory autoimmune diseases subjects who meet the inclusion criteria will receive intravenous JY231 injection. JY231 injection infusion will produce CAR-T cells in the body.
Primary Outcome Measure
Incidence of adverse events(AE) after infusion [ Time Frame: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24 ]
Central Contacts
- Liang Zou, Doctor+86 186 0270 1800
- Xiaoya Du+86 27 8533 2028
Related Studies
- A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)Recruiting · Center for International Blood and Marrow Transplant Research · Birmingham, Alabama
- Comparative Autoantibody and Immunologic Cell Marker StudyEnrolling By Invitation · Emory University · Atlanta, Georgia
- Maternal Autoimmune Disease Research Alliance (MADRA) RegistryRecruiting · Duke University · Durham, North Carolina
- Collection and Distribution of Biospecimens for Novel Research UsesRecruiting · iSpecimen Inc · Huntsville, Alabama