FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients.

StatusWithdrawn
PhaseEarly Phase 1
Started

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Record History

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  1. Trial status changed: Suspended → Withdrawn Show 4 more changesShow less
    • Enrollment target: estimated 9 to confirmed 0
    • Sponsor's reason: Enrollment is suspended to address regulatory requirements. Follow-up of currently enrolled participants continues as planned. to No participants
    • Study completion date changed from estimate of Nov 30, 2041 to Apr 30, 2026
    • Eligibility criteria expanded, about 2 words
  2. Trial status changed: Enrolling by Invitation → Suspended Sponsor's reason: Enrollment is suspended to address regulatory requirements. Follow-up of currently enrolled participants continues as planned.v3
  3. Primary endpoint(s) modifiedv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a single-center, open-label, single-dose exploration clinical trial for treating patients with partially relapsed/refractory autoimmune diseases by infusing FIT-(BCMA+CD19)-CAR-T cells after pre-treatment with cleansing therapy. In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Trial Details
NCT Number NCT07604792
Lead Sponsor Beijing Boren Hospital
Conditions
(from sponsor)		 Autoimmune Diseases
Related terms Autoimmune Diseases
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov