Trial Profile

A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 06 May 2025

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At a glance

Drugs SYNCAR-001 (Primary) ; SYNCAR-001 (Primary)
Indications Diffuse scleroderma; Lupus nephritis; Systemic lupus erythematosus
Focus Adverse reactions
Sponsors Synthekine

27 Apr 2025 Planned initiation date (estimated date of first patient enrollment) changed from 1 Mar 2025 to 1 Apr 2025.
03 Mar 2025 Planned number of patients changed from 42 to 48.
16 Jan 2025 Planned initiation date changed from 1 Dec 2024 to 1 Mar 2025.

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