IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients
NCT06690359 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-11-26
Summary
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
Conditions
Interventions
- COMBINATION_PRODUCT
-
IM19 chimeric antigen receptor T cell injection
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
Sponsors & Collaborators
-
Beijing Immunochina Medical Science & Technology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
xiangmei Chen, doctorate · Chinese PLA General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-13
- Primary Completion
- 2025-08-04
- Completion
- 2026-12-20
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