A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases

Study acronym: in vivo CAR-T
StatusRecruiting
PhasePhase 1
SponsorTherorna
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later May 1, 2026 → May 1, 2027
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Record History

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  1. Primary completion pushed from May 1, 2026 to May 1, 2027
    • Study completion pushed from Jan 30, 2027 to May 30, 2027
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Therorna
2 trials monitored
See 1 trial at risk
Lupus (SLE)
667 trials monitored
See 27 trials at risk
Scleroderma
324 trials monitored
See 14 trials at risk
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular RNA encoding the CD19 chimeric antigen receptor (CAR), which is a therapeutic biological product. It is clinically intended for the treatment of various relapsed and refractory B cell-related autoimmune diseases, such as systemic lupus erythematosus, sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome.
Trial Details
NCT Number NCT07413341
Lead Sponsor Therorna
Conditions
(from sponsor)		 Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy, ANCA Associated Systemic Vasculitis
Related terms Lupus Erythematosus, Systemic, Myositis, Scleroderma, Systemic, Sjogren's Syndrome
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov