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CD19 and BCMA CAR-T cells were infused into complete remission acute leukemia patients with PTR sequentially, with（1.0-2.0）×10e7/kg respectively. Each patient was followed up for 1 years.

Sequential infusion of CD19 and BCMA autologous chimeric antigen receptor T cells, the infusion dose was determined according to the body weight of the subject and the effective content of cell preparation.

CAR-T infusion

Xiaowen Tang, Ph.D

xiaowen tang, Ph.D

Haiping Dai, Ph.D

Alloimmune-mediated platelet transfusion refractoriness(PTR) was usually caused by repeated blood transfusions and pregnancy and accounts for about 20-25% of PTR patients. Patients with acute leukemia need repeated platelet infusion in myelosuppression period after chemotherapy, and PTR incidence is more higher.PTR was associated with adverse events,including longer hospital stays,severe hemorrhages and an increased risk of early deaths and may have a negative impact on the success of HSCT. The current management of patients with PTR includes specific transfusion strategies, IVIG, rituximab,thrombopoietin-receptor agonists(TPO-RA) ,bortezomib or splenectomy,have been largely unsatisfactory. As we know, HLA antibodies are mainly secreted by the plasma cells. Researchers want to see if sequential infusion of CD19 and BCMA CAR-T cells can clear the B cells and plasma cells, can help increase platelet levels and reduce bleeding in patients with platelet transfusion refractoriness. To see if sequential infusion can increases platelet levels more after a transfusion. To see if it reduces the chance of bleeding. Adults 16-65 years old who diagnosed with acute leukemia in CR and alloimmune platelet transfusion refractoriness.

The patients will receive infusion of CAR T-cells targeting CD19 and BCMA to confirm the safety and efficacy of CD19 and BCMA CAR T-Cells Sequential infusion in acute leukemia with alloimmune-mediated platelet transfusion refractoriness.

Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL

Sequential Infusion of CD19 and BCMA Chimeric Antigen Receptor T Cells to Improve Alloimmune-mediated Platelet Transfusion Refractoriness in Patients With Acute Leukemia in Complete Remission

To evaluate the safety and efficacy of sequential infusion of CD19 and BCMA CAR-T cells to improve PTR, estimate by platelet increment, defined as Corrected Count Increment (CCI) \>7500/μL at 10-60 min together with CCI\>5000/μL at 18-24 hrs post platelet transfusion in patients with platelet transfusion refractoriness.

Adverse events are evaluated with CTCAE V5.0.

To investigate the possible mechanisms of sequential infusion in alloimmune-mediated PTR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL	NCT04846439	Platelet Transf... Acute Leukemia ...	CAR-T infusion	16 Years - 65 Years	The First Affiliated Hospital of Soochow University
Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL	NCT04846439	Platelet Transf... Acute Leukemia ...	CAR-T infusion	16 Years - 65 Years	The First Affiliated Hospital of Soochow University

Spots Global Cancer Trial Database for platelet transfusion refractoriness