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RECRUITING
NCT07144462
EARLY_PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide (C)

Specified dose on specified days

GENETIC

NEUK203-215 Injection

Specified dose on specified days

Locations (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China