Universal STAR-T Cell Injection in R/R Autoimmune Diseases.
ConditionImmune Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJian Zhu
About this trial
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.
This study evaluates the safety and efficacy of universal STAR-T cells in patients with R/R CTD-associated Immune Thrombocytopenia (CTD-ITP). Approximately 9 patients aged 18-65 will receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells/kg. The main purpose of exploratory clinical research is to explore the efficacy and safety of universal STAR-T cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.
Eligibility criteria
Qualifiers
Age ranges from 18 to 65 years old (including threshold), regardless of gender.
Confirmed diagnosis of a connective tissue disease (CTD) according to the latest international classification criteria, including but not limited to Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Antiphospholipid Syndrome (APS), and Undifferentiated Connective Tissue Disease (UCTD).
Bone marrow morphology consistent with the characteristics of immune thrombocytopenia (ITP).
Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).
Disqualifiers
Individuals with a severe history of drug allergies or those with an allergic constitution;
Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);
Subjects whose cardiac function cannot tolerate the study interventions;
Trial design
Treatments tested in this trial
- Universal STAR-T Cell
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Jian Zhu
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov