A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases
NCT ID: NCT07144462
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
8 participants
INTERVENTIONAL
2025-09-04
2027-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental group
NEUK203-215 Injection+Drug:Fludarabine+Drug:Cyclophosphamide
Fludarabine
Specified dose on specified days
Cyclophosphamide (C)
Specified dose on specified days
NEUK203-215 Injection
Specified dose on specified days
Interventions
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Fludarabine
Specified dose on specified days
Cyclophosphamide (C)
Specified dose on specified days
NEUK203-215 Injection
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4\) Within 6 months before screening, any of the following cardiovascular events: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac disease.
5\) Malignancy within the past 5 years. 6) Clinically significant chronic or intermittent bleeding within 60 days before the screening visit.
7\) Prior solid-organ (e.g., heart, lung, kidney, liver) or hematopoietic stem-cell/bone-marrow transplantation.
8\) At screening: positive HBsAg and/or HBcAb with HBV DNA detectable or above the lower limit of quantitation; positive HCV antibody with HCV RNA detectable or above the lower limit of quantitation; positive HIV antibody; positive syphilis test (except biologic false-positive results).
9\) Major surgery within 4 weeks before screening. 10) Live or live-attenuated vaccine received within 4 weeks before screening. 11) Uncontrolled concurrent medical conditions. 12) Documented history of neurologic or psychiatric disorders. 13) Any other factor that, in the investigator's judgment, could require premature withdrawal from the study.
18 Years
65 Years
ALL
No
Sponsors
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Neukio Biotherapeutics (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025SL066
Identifier Type: -
Identifier Source: org_study_id
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