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An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA U CAR-T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease

NCT07241468 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-02-06

No results posted yet for this study

Summary

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease

Conditions

  • Relapsed/Refractory Immune Nephropathy
  • Relapsed/Refractory Immune-mediated Kidney Disease

Interventions

BIOLOGICAL

anti-CD19/BCMA U CAR T

To evaluate the safety and effectiveness of anti-CD19/BCMA CAR T cells (KN3601) in patients with immune nephropathy. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19/BCMA U CAR T cells infusion.

Sponsors & Collaborators

  • Rui Therapeutics Co., Ltd

    collaborator INDUSTRY

  • Changhai Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07241468 on ClinicalTrials.gov