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Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy

StatusNot Yet Recruiting
PhasePhase 1
Started
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Record status
This record was last updated September 22, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Start date: Aug 27, 2025 to Dec 27, 2025v3
  2. Enrollment target: 6 to 12v2 Show 8 more changesShow less
    • Primary completion date: Sep 30, 2025 to Sep 30, 2026
    • Start date: Jul 27, 2025 to Aug 27, 2025
    • Primary endpoints: 1 to 2
    • Interventions: CNCT19 cell injection (Drug) to Inaticabtagene Autoleucel Injection (Drug)
    • Eligibility criteria shortened, about 306 words
    • Secondary endpoints expanded, about 12 words
    • Study description expanded, about 127 words
    • Study title shortened, about 15 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, open-label, single-arm Phase I clinical trial to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection treatment in autoimmune hemolytic anemia that has failed at least three lines of treatment.
Trial Details
NCT Number NCT07091370
Lead Sponsor Juventas Cell Therapy Ltd.
Conditions
(from sponsor)		 AIHA - Cold Autoimmune Hemolytic Anemia
Related terms Anemia, Hemolytic, Autoimmune
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov