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 | Recruiting Early Phase 1

• 1 other identifier: CHEC2025-362
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicity (DLT)

  To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy

  up to 52 weeks after infusion

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy

  up to 52 weeks after infusion

Secondary Outcomes (4)

• The overall response rate (ORR)

  up to 52 weeks after infusion

• Disease control rate (DCR)

  up to 52 weeks after infusion

• B cell depletion rate

  up to 52 weeks after infusion

• B cell reconstitution

  up to 52 weeks after infusion

Study Arms (1)

anti-CD19/BCMA U CAR T cells

EXPERIMENTAL

Biological: anti-CD19/BCMA U CAR T

Interventions

anti-CD19/BCMA U CAR T BIOLOGICAL

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.

anti-CD19/BCMA U CAR T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years old and ≤ 70 years old, male or female;
• B cell CD19 positive expression in peripheral blood detected by flow cytometry;
• The functions of critical organs meet the following requirements:
• Neutrophil count ≥ 1 x 10\^9/L, Hemoglobin ≥60g/L, platelets ≥ 50×109/L,
• Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN,
• Coagulation function: International standardized ratio (INR) ≤ 1.5x ULN, prothrombin time (PT) ≤1.5 x ULN,
• Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥55%.
• Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negative serum HCG test within 7 days prior to study enrollment and are not lactating;
• Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
• High-risk or relapsed/refractory primary membranous nephropathy
• Primary membranous nephropathy diagnosed pathologically by renal biopsy;
• Meets the clinical criteria for high-risk or recurrent/refractory membranous nephropathy, defined as:
• Subjects at risk who meet any of the following criteria: a) estimated glomerular filtration rate (eGFR, CKD-EPI equation) \<60 mL/min/1.73m², and/or urine protein \>8g/day persisting for more than 6 months;b) normal GFR, urinary protein \>3.5 g/d, treated with ACEI/ARB for 6 months, urinary protein reduction \<50%, and serum albumin \<25 g/l or aPLA2R \>50 RU/mL;
• Refractory membranous nephropathy subjects are defined as those who have shown poor response or resistance to previous immunosuppressive treatments (including corticosteroids and/or cytotoxic drugs, immunosuppressants and/or biologics), defined as persistent proteinuria ≥3.5g/day with a reduction of \<50% compared to baseline;
• Recurrent membranous nephropathy is defined as a relapse (24-hour urinary protein ≥3.5 g) in subjects who have achieved complete or partial remission following treatment;

You may not qualify if:

• Subjects known to have allergic reactions, hypersensitivity, intolerance, or contraindications to CD19/BCMA universal CAR-T or any drug components that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or who have previously experienced severe allergic reactions;
• The subject has or is suspected of having uncontrolled or treatable fungal, bacterial, viral, or other infections;
• Subjects with central nervous system disorders caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
• Subjects with more serious heart conditions, such as angina, myocardial infarction, heart failure, and arrhythmias;
• Subjects with congenital immunoglobulin deficiency;
• The subject has other malignant tumours (excluding non-melanoma skin cancer and carcinoma in situ of the cervix, bladder cancer, and breast cancer with disease-free survival of over 5 years);
• Subjects with end-stage renal failure;
• Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have peripheral blood HBV DNA titres above the detection limit; subjects who are positive for hepatitis C virus (HCV) antibodies and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibodies; subjects who test positive for syphilis;
• Subjects have mental illness and severe cognitive impairment;
• Subjects who have participated in other clinical trials within 6 months prior to enrolment;
• Female participants who are pregnant or planning to conceive;
• Subjects with hypertension and diabetes uncontrolled by medication;
• Researchers believe that there are other reasons why some subjects cannot be included in this study;
• Relapsed/Refractory Primary Membranous Nephropathy
• Secondary membranous nephropathy (e.g., hepatitis B, systemic lupus erythematosus, drug-associated, malignancy-associated, etc.), or in combination with other renal diseases confirmed by renal biopsy;

Sponsors & Collaborators

• Changhai Hospital: lead
• Rui Therapeutics Co., Ltd: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhiyong Guo, Dr

CONTACT

86-021-31161406; chguozhiyong@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)