An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor NK Cell Injections (KN5501) in the Treatment of Relapsed/Refractory Immune Nephropathy

Changhai Hospital1 site in 1 country36 target enrollmentJune 21, 2024

ConditionsNephropathy

Interventionsanti-CD19 CAR NK cells

Overview

Phase: Early Phase 1
Intervention: anti-CD19 CAR NK cells
Conditions: Nephropathy
Sponsor: Changhai Hospital
Enrollment: 36
Locations: 1
Primary Endpoint: Incidence of Dose-Limiting Toxicity (DLT)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cell injection (KN5501) in patients with immune nephropathy. 36 patients are planned to be enrolled in the dose-escalation trial. The primary endpoints are DLT and TEAEs. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR)

Registry

clinicaltrials.gov

Start Date

June 21, 2024

End Date

June 20, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Changhai Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: ≥ 18 years old and ≤ 70 years old, male or female;
•Positive CD19 expression in peripheral blood B cells as determined by flow cytometry;
•The functions of important organs meet the following requirements:
•Bone marrow hematopoietic function: a. White blood cell count ≥ 3 x 10\^9/L b. Neutrophil count ≥ 1 x 10\^9/L (no colony-stimulating factor treatment within 2 weeks before examination); c. Hemoglobin ≥60g/L.
•Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN(excluding Gilbert syndrome, total bilirubin ≤ 3.0 x ULN)
•Coagulation function: International standardized ratio (INR) ≤ 1.5 x 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.
•Criteria for Recurrent/refractory primary membranous nephropathy