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RECRUITING
NCT06826430
PHASE1

Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia

Sponsor: Juventas Cell Therapy Ltd.

View on ClinicalTrials.gov

Summary

This is a single-arm, open-label,phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.

Official title: A Multi-center, Open-label, Single-arm Phase I Clinical Study to Evaluate the Safety and Tolerability of Inaticabtagene Autoleucel Injection in Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-03-01

Completion Date

2027-12-31

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

DRUG

Inaticabtagene autoleucel Injection

Inaticabtagene autoleucel Injection, the autologous 2nd generation CD19-directed CAR-T cells, will be administered by vein. Before CAR-T infusion,patients will get a 3-4 days lymphodepletion therapy with fludarabine and cyclophosphamide.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China