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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.
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2025-09-04
Completion Date
2027-01-14
Last Updated
2026-07-15
Healthy Volunteers
No
Conditions
Interventions
Fludarabine
Specified dose on specified days
Cyclophosphamide (C)
Specified dose on specified days
NEUK203-215 Injection
Specified dose on specified days
Locations (1)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China