NCT06553898

Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS

Study of Therapeutic Efficacy of Anti-B Cell Maturation Antigen（BCMA）/Cluster of Differentiation 70(CD70 )CAR-T Cells in Patients With Multi-drug Resistant SRNS

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS

Detailed description

At present, there is no effective treatment for Multi-drug resistant nephrotic syndrome (MDR-SRNS), which has a high risk of progression to kidney failure, and about 55% of patients will have disease recurrence after receiving kidney transplantation, which is in urgent need of new treatment methods. CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognition.Since 2019, CAR-T cell therapy has been successfully applied to autoimmune diseases. Although no clinical data related to CAR-T treatment of nephrotic syndrome has been disclosed, CAR-T is effective for systemic lupus erythematosus and systemic sclerosis.Many kinds of autoimmune diseases such as chemical syndrome and idiopathic inflammatory dermatomyositis have good therapeutic effect. These results suggest that the therapeutic effect of CAR T cells may not be limited to systemic lupus erythematosus, but may also play a role in several different B-cell-mediated and autoantibody-driven human autoimmune diseases, which is expected to bring breakthroughs in the treatment of MDR-SRNS.The purpose of this study is to assess the safety and efficacy of the anti-BCMA/CD70 CAR-T cells in the treatment of patients with MDR-SRNS.

Conditions

• Multi-Drug Resistant Nephrotic Syndrome
• CAR-T Cell Therapy

Interventions

Type	Name	Description
BIOLOGICAL	anti-BCMA/CD70 CAR-T cells	Three dose groups (0.3×105/kg, 1×105/kg, 3×105/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2024-08-14
• Last updated: 2025-08-29

Locations

1 site across 1 country: China