The goal of this clinical trial is to learn whether CM336, a BCMA/CD3 bispecific antibody, can improve treatment outcomes when combined with isatuximab, lenalidomide, and bortezomib in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination. The main questions it aims to answer are: How many participants achieve minimal residual disease (MRD) negativity after 9 treatment cycles? What side effects occur during treatment with CM336 combined with isatuximab, lenalidomide, and bortezomib? How many participants respond to treatment, and how long do those responses last? How long do participants remain free from disease progression, and how long do they survive after starting treatment? All participants will receive the study treatment. There is no comparison group in this study. Participants will: Receive CM336 by subcutaneous injection together with isatuximab, lenalidomide, and bortezomib in 28-day treatment cycles. Undergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety. Have stem cells collected after the first 3 treatment cycles if appropriate. Continue treatment for up to 18 cycles, followed by maintenance treatment with isatuximab and lenalidomide until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Be monitored throughout the study for side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CM336 is administered subcutaneously (SC) using a step-up dosing regimen, followed by a target dose of 160 mg. During Cycle 1, CM336 is administered weekly; from Cycle 2 through Cycle 18, it is administered every 4 weeks.
Isatuximab is administered intravenously (IV) at 10 mg/kg. It is given weekly during Cycle 1, every 2 weeks during Cycles 2-12, and every 4 weeks during Cycles 13-18.
Bortezomib is administered subcutaneously (SC) at 1.3 mg/m² once weekly during Cycles 1-18.
Lenalidomide is administered orally at 25 mg once daily on Days 1-21 of each 28-day cycle.
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGMinimal residual disease (MRD) negative rate
Time frame: After 9 cycles (each cycle is 28 days)
Incidence and severity of adverse events (AEs)
Time frame: From the first dose of CM336 through 30 days after the last dose of CM336, up to approximately 18 months.
Duration of MRD negativity
Time frame: From the date of first documented MRD negativity until disease progression, death, or end of follow-up, whichever occurs first, assessed up to approximately 36 months.
Hematological Overall Response Rate (ORR)
Time frame: Up to 18 treatment cycles, each cycle is 28 days
Progression-free survival (PFS)
Time frame: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, up to approximately 36 months.
Overall survival (OS)
Time frame: From the first dose of study treatment until death from any cause, up to approximately 36 months.
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