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

Sponsor
Nanjing Bioheng Biotech Co., Ltd.
Study ID
NCT06548607
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • ANCA Associated Vasculitis
  • Autoimmune Diseases
  • Idiopathic Inflammatory Myopathies
  • SLE (Systemic Lupus)
  • Sjogren's Syndrome
  • Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CD19 or CD19-BCMA CAR-T — DRUG
    CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Study Details

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.

Key Dates

First listed
Aug 12, 2024
Start date
Sep 14, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    RD06-04；RD06-05

Primary Outcome Measure

The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment [ Time Frame: 2 years ]

Central Contacts

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