NCT06690359

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

Evaluation of IM19 CAR-T Cell Therapy for IgA Nephropathy With Urinary Protein and Renal Dysfunction Safety and Efficacy of Patients With Primary Membranous Nephropathy and Those at Medium to High Risk Clinical Research

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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 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. The investigators will evaluate the changes in urinary protein and eGFR relative to baseline values within 6 months of the first infusion, the rate of reaching the threshold, and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days after the infusion. And evaluate the long-term efficacy, namely the changes in urinary protein and eGFR relative to baseline values and the ratio of reaching threshold values after 360 days of cell transfusion. The retention amount and duration of IM19 CAR-T cells in the peripheral blood of subjects. 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. Three subjects will be enrolled at each dose to evaluate the changes and disappearance rate of PLA2Rab relative to baseline within 6 months after the first infusion, as well as the overall response rate (CR+PR), complete response rate, partial response rate, and incidence of adverse events related to IM19 CAR-T cell infusion within 28 days after IM19 CAR-T cell infusion. And evaluate the long-term efficacy, that is, assess the rate of PLA2Rab changes and disappearance relative to baseline, overall response rate (CR+PR), complete response rate, and partial response rate of the subjects after 360 days of cell transfusion. The retention amount and duration of IM19 CAR-T cells in the peripheral blood of subjects.

Conditions

• IgA Nephropathy
• Membranous Nephropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-13
• Primary completion: 2025-08-04
• Completion: 2026-12-20
• First posted: 2024-11-15
• Last updated: 2024-11-26