JY231(JY231) Injection for the Treatment of Refractory Autoimmune Diseases (ADs)

Sponsor
He Huang
Study ID
NCT06887985
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JY231 Injection — DRUG
    This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo chimeric antigen receptor T-Cell (CAR-T cell) therapy in patients with relapsed refractory B-cell leukemia. Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 15 years to determine if the disease is under control.

Study Details

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with Refractory Autoimmune Diseases (ADs). It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of Refractory Autoimmune Diseases (ADs).

Key Dates

First listed
Mar 21, 2025
Start date
Mar 31, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A single-center, open, single arm study
    JY231 injection for the treatment of refractory autoimmune diseases (ADs) subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject.

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 ]

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