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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Description: A single intravenous infusion of anti-CD19/BCMA CAR gene vector injection(dose-escalating infusion of 1.0-4.0 x10\^6 TU/kg).
Hunan Siweikang Therapeutic Co.Ltd
Changsha, Hunan, China
RECRUITING1. 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
Time frame: up to 1 years
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
Time frame: up to 1 years
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
Time frame: up to 1 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.