Phase
Condition
Connective Tissue Diseases
Collagen Vascular Diseases
Treatment
anti-CD19 CAR NK cells
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects voluntarily participate in this clinical study and sign the InformedConsent Form (ICF) and are willing to follow and be able to complete all trialprocedures
Subjects disease status of enrolment: not complete response (CR) after standardtreatment; 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/sexcriteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3times 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 orbiologic agent for at least 2 weeks prior to enrollment
Exclusion
Exclusion Criteria:
Subjects with known severe allergic reactions, hypersensitivity, contraindication toany medications during the trial (cyclophosphamide, fludarabine, tozumabs), orsubjects with a history of severe allergic reactions
Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmannsyndrome, 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 systemicfungal 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 orprimary cervical cancer; subjects with inactive tumors
Subjects with more pronounced bleeding tendencies, such as gastrointestinalbleeding, coagulation disorders, and hypersplenism
Subjects were treated with systemic corticosteroids concomitantly within 2 weeksprior to treatment
Subjects with unstable angina, symptomatic congestive heart failure or myocardialinfarction 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 subjectsor interfere with the clinical trial outcome
Study Design
Connect with a study center
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu 212001
ChinaActive - Recruiting
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu 212001
ChinaActive - Recruiting
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