JY231(Internal Clinical Drug Code) Injection for the Treatment of Refractory Autoimmune Diseases
NCT06243159 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-02-06
Summary
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of refractory autoimmune diseases
Conditions
Interventions
- GENETIC
-
JY231
Infusion of JY231 Injection by dose of 1-10×10\^6 TU/kg、 1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)
Sponsors & Collaborators
-
Shanxi Bethune Hospital
lead OTHER
Principal Investigators
-
liyun zhang, Doctoral · Shanxi Bethune Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-08
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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