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Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Primary completion date: Jul 29, 2026 to Dec 31, 2026
    • Study completion date: Jul 29, 2027 to Dec 31, 2027
    • Interventions: RD06-04 or RD06-05 CART Cell Injection (Drug) to CD19 or CD19-BCMA CAR-T (Drug)
    • Eligibility criteria revised
    v5
  2. Interventions: RD06-04 CART Cell Injection (Drug) to RD06-04 or RD06-05 CART Cell Injection (Drug)
    • Study title expanded, about 2 words
    v4
  3. Start date: Jul 29, 2024 to Sep 14, 2024v3
  4. Eligibility criteria expanded, about 2 wordsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.
Trial Details
NCT Number NCT06548607
Lead Sponsor Nanjing Bioheng Biotech Co., Ltd.
Conditions
(from sponsor)		 SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies, Sjogren's Syndrome, Autoimmune Diseases
Related terms Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Autoimmune Diseases, Lupus Erythematosus, Systemic, Myositis, Scleroderma, Systemic, Sjogren's Syndrome
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov