Actively Recruiting
A Phase II Study of BCMA/CD3 Bispecific Antibody Combined With CD38 Monoclonal Antibody in Newly Diagnosed Multiple Myeloma Patients With Severe Renal Impairment
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment regimen combining CM336 and isatuximab for patients newly diagnosed with multiple myeloma who have severe kidney impairment, specifically with an estimated glomerular filtration rate below 30 mL/min. This Phase II, single-center, single-arm, open-label trial aims to assess the effectiveness and safety of this combination therapy in this particular patient group. Participants will receive three consecutive cycles of induction therapy. CM336 is given subcutaneously using a step-up dosing schedule until reaching a target dose, which is then administered once weekly. Isatuximab is administered intravenously at 10 mg/kg weekly during the first cycle and every two weeks during the second and third cycles. During the study, researchers will monitor kidney response at the end of the third cycle, as well as overall blood cancer response, minimal residual disease negativity, and reduction of certain blood proteins related to the disease. Safety is closely followed through recording adverse events. Participants will be observed for progression-free and overall survival for up to about 24 months after starting treatment. The total study duration includes screening, treatment cycles, and follow-up assessments to fully evaluate outcomes and safety.
CONDITIONS
Brief Title
CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Severe Renal Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Newly diagnosed symptomatic multiple myeloma according to IMWG criteria
- Received no more than one cycle of prior anti-myeloma therapy excluding immunotherapy
- Measurable disease at diagnosis by serum or urine M-protein or abnormal serum free light chain ratio
- Severe myeloma-related renal impairment with eGFR less than 30 mL/min due to cast nephropathy
- ECOG performance status score of 2 or less
- Adequate hematological, hepatic, and coagulation function as specified
- No active concomitant malignancies or malignancies with expected survival under 12 months
- Willingness and ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Diagnosis of smoldering multiple myeloma, MGUS, Waldenström's macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia
- Central nervous system or meningeal involvement
- Severe or uncontrolled cardiac diseases including recent myocardial infarction or severe arrhythmias
- Active infections such as HIV, active hepatitis B or C, syphilis, active tuberculosis, or other infections unsuitable for study
- Concurrent malignancies or severe diseases compromising safety or study completion
- Pregnant or lactating women
- History of severe allergic reactions or hypersensitivity to study drugs
- Unable or unwilling to provide informed consent
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 3 cycles of 28 days each
Participants receive 3 cycles of induction therapy with CM336 in combination with isatuximab.
Weekly visits during Cycle 1, and every two weeks during Cycles 2 and 3
Duration - Up to approximately 24 months
Participants are monitored for safety, hematological response, and disease progression after treatment ends.
Visits occur periodically up to 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China, 300000
Actively Recruiting
Research Team
G
Gang An, PhD & MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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