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

Sponsor
Nanjing Bioheng Biotech Co., Ltd.
Study ID
NCT07203404
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • ANCA Associated Vasculitis
  • ANCA-Associated Glomerulonephritis
  • Anti-GBM Disease
  • IIM
  • IgA Nephropathy
  • LN
  • MN
  • SLE
  • SSc

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RD06-05 CART Cell Injection — DRUG
    CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide

Study Details

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).

Key Dates

First listed
Oct 2, 2025
Start date
Jul 24, 2025
Status verified
Jul 2026
Primary completion
Jul 23, 2027
Completion
Jul 23, 2028

Study Design

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

Arms

  • Experimental: 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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