IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients

Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study ID
NCT06690359
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

Eligibility Criteria

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

Interventions

  • IM19 chimeric antigen receptor T cell injection — COMBINATION_PRODUCT
    IgA nephropathy: The investigators plan to recruit IgA nephropathy subjects with urinary protein and renal dysfunction who meet the inclusion and exclusion criteria. They will receive Beijing Zaimiao Biological IM19 CAR-T cell infusion therapy at doses of 0.5 × 10 \^ 8 and 1 × 10 \^ 8 CAR-T cells, with 3 subjects enrolled at each dose Primary membranous nephropathy: The investigators plan to recruit primary membranous nephropathy subjects who meet the inclusion and exclusion criteria and receive IM19CAR-T cell infusion therapy at doses of 0.5 × 10 \^ 8 and 1 × 10 \^ 8 CAR-T cells, with 3 subjects enrolled at each dose

Study Details

IM19 CAR-T cell therapy for IgA nephropathy patients with urinary protein and renal dysfunction, as well as patients with intermediate to high-risk primary membranous nephropathy

Key Dates

Start date
Dec 13, 2024
Status verified
Nov 2024
Primary completion
Aug 4, 2025
Completion
Dec 20, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IgA nephropathy subjects with urinary protein and renal insufficiency
    The study plans to recruit 6 patients with IgA nephropathy accompanied by urinary protein and renal dysfunction, including 3 patients receiving a dose of 0.5 × 10 \^ 8 CAR-T cells and 3 patients receiving a dose of 1 × 10 \^ 8 CAR-T cells
  • Experimental: Primary membranous nephropathy
    Recruiting 6 patients with medium to high-risk PMN, including 3 patients receiving 0.5 × 10 \^ 8 CAR-T cell dose and 3 patients receiving 1 × 10 \^ 8 CAR-T cell dose, for corresponding doses of IM19 CAR-T cell infusion therapy

Primary Outcome Measure

IgA nephropathy-Main safety endpoint（Adverse event incidence rate） [ Time Frame: IM19 CAR-T cell reinfusion within 28 days ]

Central Contacts

Related Studies