This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells(QT-019C) in Patients With Refractory Primary Immune Thrombocytopenia.
1. Participants aged ≥18 years and ≤75 years, regardless of gender.
2. Clinically diagnosed with primary immune thrombocytopenia for no less than 6 months, with platelet counts < 30×10^9/L in two separate tests conducted within 15 days before the initiation of study treatment, with at least 7 days between the tests.
3. Presence of any anti-platelet glycoprotein autoantibody (GPIb/GPIX/GPIIb/GPIIIa/GMP140) positive.
4. Meet the criteria for refractory ITP: previously received first-line and/or second-line ITP treatment (first-line treatment includes corticosteroids or immunoglobulins; second-line treatment includes thrombopoietin receptor agonists (such as eltrombopag, romiplostim), rituximab, splenectomy, etc.), but ineffective (post-treatment platelet count <30×10^9/L, or platelet count increase less than twice the baseline value, or presence of bleeding), or relapse after initial response or difficult to maintain after discontinuation.
1. Secondary thrombocytopenia caused by myelodysplastic syndromes, splenic hyperfunction, autoimmune diseases, early aplastic anemia, atypical aplastic anemia, and thrombotic thrombocytopenic purpura, among other causes.
2. Bone marrow examination results during the screening phase indicate bone marrow fibrosis MF>2 (European expert consensus scoring criteria for bone marrow fibrosis, Thiele et al., 2005) or the bone marrow examination suggests the presence of other primary conditions causing thrombocytopenia aside from ITP.
NYHA class II or IV congestive heart failure;
Myocardial infarction within 6 months before signing the ICF, or having undergone coronary artery bypass grafting (CABG) or coronary artery stent implantation;
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Shanghai Xiniao Biotech Co., Ltd.
Collaborator