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;
Single group
QT-019C
DrugQT-019C is a chimeric antigen receptor T-cell (CAR-T) therapy targeting both BCMA and CD19. Participants will undergo leukocyte separation to collect monocytes for the manufacturing of QT-019C. Before infusion(Day -5), participants receive lymphodepletion with cyclophosphamide for 3 days and undergo a safety check on Day -1. Eligible participants will receive an intravenous infusion of QT-019C on Day 0. The period from the infusion until Day 28 will be the dose-limiting toxicity (DLT) observation period, during which the occurrence of DLT events and other adverse events will be closely monitored, as well as changes in other indicators (such as pharmacokinetics, pharmacodynamics, and preliminary efficacy). Participants are monitored for safety and efficacy for up to 24 months.
The number and severity of dose-limiting toxicity (DLT)events
DLT will be graded according to the NCl Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, andthe ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with lmmune Effector Cells.
The total number, incidence, and severity of Adverse Events(AEs)
The total number, incidence, and severity of Adverse Events(AEs)
Clinical response of relapsed/refractory ITP
Complete response (CR) rate or Response (R) rate of administering QT-019C in the treatment of refractory ITP. CR is defined as a platelet count ≥100×10⁹/L. PR is defined as a platelet count ≥30×10⁹/L, with an increase of at least two times from baseline, and no active bleeding.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Shanghai Xiniao Biotech Co., Ltd.
Collaborator
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