The goal of this clinical trial is to evaluate whether CM336, a BCMA/CD3 bispecific antibody, in combination with daratumumab and lenalidomide can induce deep and durable responses in adults with transplant-ineligible newly diagnosed multiple myeloma (NDMM). 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 6 treatment cycles? * What side effects occur during treatment with CM336 combined with daratumumab and lenalidomide? * How many participants respond to treatment and how deep are these responses? * How long does MRD negativity and treatment response last? * How long do participants remain free from disease progression?
All participants will receive the study treatment. There is no comparison group in this study.
Participants will:
* Receive CM336 by subcutaneous injection together with subcutaneous daratumumab and oral lenalidomide in 28-day treatment cycles. * Undergo regular blood tests, bone marrow examinations, MRD assessments, and disease assessments to monitor treatment response and safety. * Be monitored throughout the study for treatment-related adverse events.
Able to understand and voluntarily sign a written informed consent form (ICF).
Age 18 to 75 years.
Newly diagnosed symptomatic multiple myeloma according to International Myeloma Working Group (IMWG) criteria. Patients who have received no more than one cycle of anti-myeloma therapy before enrollment are eligible.
Age ≥65 years;
Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary or secondary plasma cell leukemia.
Central nervous system (CNS) involvement or clinical evidence of leptomeningeal involvement.
Known intolerance, hypersensitivity, allergy, or contraindication to daratumumab, lenalidomide, or CM336.
Unstable angina;
Single group
CM336 (BCMA/CD3 bispecific antibody)
DrugCM336 is administered subcutaneously (SC) using a step-up dosing regimen of 3 mg on Day 1, 20 mg on Day 4, 80 mg on Day 7, and 160 mg on Day 10. The first administration of the target dose is considered Cycle 1 Day 1 of the target-dose phase. During Cycle 1, CM336 160 mg is administered once weekly. From Cycle 2 through Cycle 18, CM336 160 mg is administered every 4 weeks.
Daratumumab
DrugDaratumumab is administered subcutaneously at a dose of 1800 mg in 28-day treatment cycles. One dose is administered on Day 0 before initiation of the CM336 step-up dosing regimen. During the CM336 target-dose treatment phase, daratumumab is administered once weekly during Cycles 1-2, every 2 weeks during Cycles 3-6, and every 4 weeks during Cycles 7-18.
Lenalidomide
DrugLenalidomide is administered orally at 25 mg once daily on Days 1-21 of each 28-day treatment cycle during Cycles 1-18. The starting dose may be adjusted for participants with renal impairment, frailty, or advanced age based on creatinine clearance and investigator judgment.
Minimal residual disease (MRD) negative rate
Proportion of participants achieving minimal residual disease (MRD) negativity after 6 treatment cycles.
Incidence and severity of adverse events (AEs)
Incidence, type, and severity of adverse events. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0.
Duration of MRD negativity
Duration of MRD negativity, defined as the time from the first documented MRD-negative assessment to the first documented loss of MRD negativity, disease progression, or death, whichever occurs first. Participants without any of these events will be censored at the date of their last evaluable MRD assessment.
Overall Response Rate (ORR)
Proportion of participants achieving partial response (PR) or better according to International Myeloma Working Group (IMWG) response criteria.
Very Good Partial Response or Better Rate (≥VGPR)
Proportion of participants achieving very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group (IMWG) response criteria.
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