This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia.
The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of treatment with VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) in combination with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia. Patients receive 3 cycles of induction therapy with VRD-based regimen followed by the first infusion of CAR-T cells. Patients then received 3 cycles of VR-based consolidation therapy, followed by ASCT and the second infusion of CAR-T cells. And R or R maintenance starts on day 100 after ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous BCMA-directed CAR-T cells, the double infusion intravenously at a target dose of (2-4)±20% x 10\^6 anti-BCMA CAR+T cells/kg respectively
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Safety and Tolerability
The incidence of treatment-emergent adverse events (TEAEs)
Time frame: 2 year
Overall response rate (ORR)
ORR(including sCR / CR / VGPR / PR, based on IMWG criteria)
Time frame: after induction therapy, 1 month after the first CAR-T cell transfusion, the consolidation therapy ends, 6 months after the second CAR-T cell transfusion
Progression free survival (PFS)
Is defined as time from first induction date to first documentation of PD, or death due to any cause, whichever occurs first.
Time frame: 1 year
Complete response rate (CRR)
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to IMWG criteria
Time frame: after induction therapy, 1 month after the first CAR-T cell transfusion, the consolidation therapy ends, 6 months after the second CAR-T cell transfusion
Overall survival (OS)
Is defined as time from first induction date to time of death due to any cause
Time frame: 1 year
MRD-negative Rate
MRD negative by flow cytometry
Time frame: after induction therapy, 1 month after the first CAR-T cell transfusion, the consolidation therapy ends, 6 months after the second CAR-T cell transfusion
Duration of Remission (DOR)
Duration from the first evaluation of at least partial remission (PR) to the onset of disease progression or death due to disease progression (whichever occurs first)
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Time frame: 2 year