Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Study ID
NCT07161193
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Diseases

Eligibility Criteria

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

Interventions

  • CD19 CAR-T cells — BIOLOGICAL
    Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Study Details

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases

Key Dates

First listed
Sep 8, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Aug 18, 2027
Completion
Nov 18, 2027

Study Design

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

Arms

  • Experimental: Experimental :CD19 CAR
    Following the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Primary Outcome Measure

Phase I:Cytokine Release Syndrome (CRS) [ Time Frame: 28 days post infusion ]

Central Contacts

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