CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT07586267
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • ANCA Associated Systemic Vasculitis
  • Autoimmune Diseases
  • IgA Nephropathy (IgAN)
  • Multi-Drug Resistant Nephrotic Syndrome
  • Systemic Lupus Erthematosus (SLE)
  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QT-219CX — BIOLOGICAL
    A universal allogeneic CAR-T cell product targeting both CD19 and BCMA

Study Details

This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .

Key Dates

First listed
May 14, 2026
Start date
May 8, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: UCAR T-cell group
    This is a single-arm, open-label study where subjects with B-cell related autoimmune diseases will undergo lymphodepletion followed by a single intravenous infusion of QT-219CX cells. The study includes a dose-escalation phase followed by a dose-expansion phase.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 0 to Day 28 post-infusion ]

Central Contacts

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