Status:
RECRUITING
A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
Lead Sponsor:
YANRU WANG
Collaborating Sponsors:
Rui Therapeutics Co., Ltd
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15...
Eligibility Criteria
Inclusion
- Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
- Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
- Age: ≥ 18 years old and ≤ 70 years old, male or female
- Subjects with estimated survival \> 12 weeks
- Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)
- ECOG performance ≤ 2
- Left ventricular ejection fraction (LVEF) ≥ 45%
- Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment
Exclusion
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions
- Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
- Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
- Subjects with grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system (CNS) diseases
- History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors
- Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
- Subjects were treated with systemic corticosteroids concomitantly within 2 weeks prior to treatment
- Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months
- Females who are pregnant, lactating, or planning a pregnancy within six months
- Subjects who have received other clinical trial treatment within 3 months
- Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 13 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06318533
Start Date
March 13 2024
End Date
March 13 2027
Last Update
May 11 2025
Active Locations (2)
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1
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212001
2
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China, 212001