CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia (NCT07652905) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia
China24 participantsStarted 2026-06-20
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to understand and voluntarily sign a written informed consent form (ICF).
. Age 18 to 75 years.
. Newly diagnosed primary plasma cell leukemia (pPCL) according to International Myeloma Working Group (IMWG) criteria, defined as either:
. Measurable disease, defined by at least one of the following:
. Adequate hepatic function, defined as:
. Adequate renal function, defined as creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
. Adequate hematologic function within 7 days prior to enrollment, defined as:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for primary plasma cell leukemia — can you confirm that my diagnosis actually fits that category, and is this the right type of leukemia for me to even consider this study?
2The trial is in Phase 2, which means researchers are still building evidence on how well and safely this combination works — given that, how does the potential benefit compare to standard treatment options that already have more established safety data for my situation?
3The trial hasn't started recruiting yet — realistically, how long might it be before it opens and I could even be considered, and is waiting that long a safe option given how aggressive plasma cell leukemia can be?
4The main thing this trial is measuring is whether patients reach MRD-negative status, meaning no detectable cancer cells — can you explain what achieving MRD negativity would actually mean for my long-term outlook, and how does that compare to outcomes we might expect from standard care?
5CM336 combined with Isa-VR is a multi-drug regimen I'm not familiar with — what are the likely side effects or risks of adding CM336 to this combination, and how would those demands fit with my current health and day-to-day life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Minimal residual disease (MRD) negative rate
Timeframe: After 9 cycles (each cycle is 28 days)
Trial details
NCT IDNCT07652905
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Participants receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or thrombopoietic agents, must have a washout period of at least 2 weeks between the last administration of growth factor support and screening assessments.
Exclusion criteria
. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia.
. Central nervous system (CNS) involvement or clinical evidence of leptomeningeal involvement.
. Known intolerance, hypersensitivity, allergy, or contraindication to CM336, isatuximab, bortezomib or lenalidomide.
. Severe and/or uncontrolled cardiovascular disease, including:
. Active infection, including:
. Concurrent active malignancy or any serious concomitant disease that, in the investigator's judgment, could compromise participant safety or interfere with study participation.
. Pregnant or breastfeeding women.
. Estimated life expectancy of less than 6 months.