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
IgA nephropathy
IgA nephropathy diagnosed through renal biopsy
When screening, urine protein should be ≥0.5g/gCr and 20mL/min/1.73m²≤eGFR<60mL/min/1.73m²
Age≥18years old
Kidney diseases other than IgA nephropathy, as well as primary and secondary nephrotic syndrome
After examination by the researchers, it was determined that the subjects had diseases that were not suitable for participation in this study, such as life-threatening conditions (such as catastrophic antiphospholipid syndrome, acute severe renal failure, and acute severe central nervous system disease manifestations)
Serious complications unrelated to IgA nephropathy
Use or increase the dosage of corticosteroids, immunosuppressants, biologics (including but not limited to CD20 monoclonal antibodies, taceptil, etc.), anticoagulants (warfarin), and n-3 fatty acids (fish oil) for the drug treatment of IgA nephropathy within 3 months
Sequential
IM19 chimeric antigen receptor T cell injection
Combination productIgA 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
IgA nephropathy-Main safety endpoint（Adverse event incidence rate）
The incidence of adverse events related to IM19 CAR-T cell reinfusion within 28 days after IM19 CAR-T cell reinfusion, as well as clinically significant laboratory test results.
IgA primary efficacy endpoint（Urinary protein ratio）
Changes in urinary protein levels (1 day, 14 days, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after initial administration) relative to baseline values and the rate of reaching the threshold
PMN primary safety endpoint（Adverse event incidence rate）
The incidence of adverse events related to IM19 CAR-T cell reinfusion within 28 days after IM19 CAR-T cell reinfusion, as well as clinically significant laboratory test results.
PMN primary efficacy endpoint（Relief rate）
Evaluate the overall response rate (CR+PR), complete response rate, and partial response rate of the subjects 6 months after the first infusion. Complete remission criteria: Urinary protein ≤ 0.3g and serum albumin\>3.5g/dl. Partial relief criteria: Urinary protein reduction\>50% compared to baseline and final 0.3g\<urinary protein ≤ 3.5g.
IgA secondary endpoint（EGFR ratio）
The ratio of eGFR levels reaching the threshold after IM19CAR-T cell reinfusion
IgA secondary endpoint（Urinary protein ratio）
The ratio of urinary protein levels reaching the threshold after IM19CAR-T cell reinfusion
PMN secondary endpoint（Relief rate）
Evaluate the rate of relative baseline changes and disappearance of PLA2Rab, overall response rate (CR+PR), complete response rate, and partial response rate in subjects after 360 days of cell transfusion
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