RecruitingEarly Phase 1NCT07144462

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases


Sponsor

Neukio Biotherapeutics (Shanghai) Co., Ltd.

Enrollment

8 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of NEUK203-215 , a healthy donor (HD) allogeneic CD19/BCMA-targeted CAR-NK cell product, in participants with severe, refractory autoimmune diseases. This study plans to conduct an interim data analysis when the cumulative enrollment reaches 50% of the total sample size. The objectives of this analysis are: (1) to summarize the safety and tolerability profile at the current dose level; (2) to preliminarily assess trends in clinical response endpoints and explore preliminary signals of drug efficacy; and (3) to preliminarily evaluate the pharmacokinetic and pharmacodynamic characteristics of the drug in humans. This analysis is exploratory in nature and is intended to accumulate preliminary clinical evidence for the drug in the target patient population.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide (C), a drug called Fludarabine, and others for people with autoimmune. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

Specified dose on specified days

DRUGCyclophosphamide (C)

Specified dose on specified days

GENETICNEUK203-215 Injection

Specified dose on specified days


Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07144462


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