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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

NCT07144462 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-07-15

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Neukio Biotherapeutics (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2027-01-14
Completion
2027-01-14

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144462 on ClinicalTrials.gov