This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed and refractory immune thrombocytopenia. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19/BCMA CAR gene vector injection
1. Age≥ 18 years old, regardless of gender. 2. Clinical diagnosis of primary immune thrombocytopenia for at least 6 months, platelet count < 30×10^9/L within 48 hours before participating in the study.
1. Thrombocytopenia caused by myelodysplastic syndrome, early aplastic anemia, atypical aplastic anemia, thrombotic thrombocytopenic purpura, etc.
Sequential
Anti-CD19/BCMA CAR gene vector injection will be injected intravenously on a one-time basis.
DrugDescription: A single intravenous infusion of anti-CD19/BCMA CAR gene vector injection(dose-escalating infusion of 1.0-4.0 x10\^6 TU/kg）.
1. Adverse events
Total number, incidence and severity of adverse events (AEs) in patients of LCAR1901 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus
2. The persistence of CAR gene vector injection
Assessing the trafficking of CAR gene vector injection in the peripheral blood at the time of each infusion as well as at each time of follow-up by flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline
Overall remission rate
Complete response (CR): Platelet count ≥ 100 × 10\^9/L and no bleeding; Partial response (PR): platelet count\<100 × 10\^9/L, but increased by at least 2 times compared to baseline platelet count, with no bleeding symptoms
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