This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with 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 combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia. Patients received 3 courses of induction therapy with VRD-based regimen followed by infusion of BCMA CAR-T cells. Patients then received 3 courses of VR consolidation therapy, followed by VR maintenance therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg.
Bortezomib, Lenalidomide and Dexamethasone
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGSafety and Tolerability
The incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 year
MRD-negative rate
achieving MRD-negative, as determined by NGS/NGF after consolidation treatment
Time frame: within 1 week after consolidation treatment
Complete response rate (CRR)
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria
Time frame: within 1 week after induction therapy, 1 month after the CAR-T cell transfusion, within 1 week after consolidation therapy
Progression free survival (PFS)
Progression free survival is defined as the time from the date of diagnosis to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Time frame: Up to 2 year
Overall Survival (OS)
Overall survival is measured from the date of diagnosis to the date of the participant's death.
Time frame: Up to 5 year
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)
Time frame: Up to 2 year
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