CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06680388
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Drug：CD19 CAR-T — DRUG
    A total of 3 dose groups were set, with dose group 1 as the starting dose, which was performed according to the traditional 3 + 3 design rule as a single intravenous infusion.

Study Details

Autoimmune diseases such as systemic lupus erythematosus (SLE), diffuse cutaneous systemic sclerosis (dcSSc), antineutrophil cytoplasmic antibody (ANCA) -associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and Sjogren's syndrome (SS) have complex etiologies and are prone to cause systemic multiple organ damage. Because patients need lifelong medication due to repeated disease recurrence, and the current treatment of the above autoimmune diseases has limited efficacy and greater side effects, so that patients bear an excessive burden of disease, therefore, there is an urgent need to explore safer and more effective treatment. Several autologous CAR-T products targeting CD19 have been marketed for the treatment of B-cell hematological malignancies. Depletion of B cells to suppress abnormal immune responses is also currently one of the popular strategies for the treatment of antibody-mediated autoimmune diseases, and many clinical studies of CAR-T against autoimmune diseases are still ongoing. Therefore, a dose escalation trial is planned to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T in patients with relapsed/refractory autoimmune diseases.

Key Dates

First listed
Nov 8, 2024
Start date
Nov 15, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: patients with relapsed/refractory moderately or severely active systemic lupus erythematosus (SLE)
    Drug：CD19 CAR-T
  • Experimental: relapsed/refractory active diffuse cutaneous systemic sclerosis (dcSSc)
    Drug：CD19 CAR-T
  • Experimental: relapsed/refractory antineutrophil cytoplasmic antibody (ANCA) -associated vasculitis (AAV)
    Drug：CD19 CAR-T
  • Experimental: relapsed/refractory idiopathic inflammatory myopathy (IIM)
    Drug：CD19 CAR-T
  • Experimental: relapsed/refractory Sjogren 's syndrome (SS)
    Drug：CD19 CAR-T

Primary Outcome Measure

Dose limiting toxicity (DLT); [ Time Frame: within 28 (+3) days after receiving the infusion. ]

Central Contacts

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