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A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment increased: 84 → 96 participants
    • Eligibility criteria expanded, about 171 words
    • Study site revised
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).
Trial Details
NCT Number NCT07203404
Lead Sponsor Nanjing Bioheng Biotech Co., Ltd.
Conditions
(from sponsor)		 SLE, LN, ANCA Associated Vasculitis, ANCA-Associated Glomerulonephritis, Anti-GBM Disease, MN, SSc, IIM +1 more
Related terms Anti-Glomerular Basement Membrane Disease, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Glomerulonephritis, IGA
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov