RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT07674147
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Autoimmune Diseases
  • IIM- Idiopathic Inflammatory Myopathies
  • IgAN - IgA Nephropathy
  • Multi-Drug Resistant Nephrotic Syndrome
  • SLE - Systemic Lupus Erythematosus
  • SSc-Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
5 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell (CAR-T), in pediatric and adolescent patients with refractory autoimmune diseases, including systemic lupus erythematosus/lupus nephritis (SLE/LN), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), multidrug-resistant nephrotic syndrome (MDR-NS), and refractory IgA nephropathy (IgAN). Approximately 30 eligible patients will be enrolled and receive a single intravenous infusion of RD06-05 at an initial dose of 6×10⁶ CAR+ T cells/kg, with a potential dose escalation to 10×10⁶ CAR+ T cells/kg following review by a Safety Review Committee (SRC).

Key Dates

First listed
Jun 29, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2030

Study Design

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

Arms

  • Experimental: RD06-05 Universal CAR-T Therapy
    Single-arm, open-label: participants receive a single intravenous infusion of RD06-05 (universal CD19/BCMA dual-targeting CAR-T cells) following a lymphodepleting regimen of fludarabine and cyclophosphamide.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) [ Time Frame: From signing of informed consent through 90 days post-infusion (for related AEs, up to 24 months post-infusion) ]

Central Contacts

Related Studies