New drug combo aims to tackle myeloma and kidney damage at once
NCT ID NCT07585760
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 4 times
Summary
This phase 2 trial is testing a combination of two drugs—CM336 (a bispecific antibody) and isatuximab (a monoclonal antibody)—in 20 people newly diagnosed with multiple myeloma who also have severe kidney impairment. The goal is to see if the treatment can improve kidney function and control the cancer. Participants receive three cycles of the drug combo, and the study tracks both kidney response and cancer response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CM336 (a bispecific antibody) and isatuximab (a monoclonal antibody)
- What this could lead to
- If successful, this combination could offer a new treatment option for multiple myeloma patients who also have severe kidney impairment, potentially improving both kidney function and cancer control.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The treatment may cause side effects, and it is not a cure—patients will likely need ongoing therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 80 years. 2. Newly diagnosed symptomatic multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) criteria. Patients who have received up to 1 cycle of prior anti-myeloma therapy are allowed to enroll. 3. Presence of measurable disease at diagnosis, meeting at least one of the following criteria: A.Serum M-protein ≥ 1 g/dL (\> 10 g/L) measured by serum protein electrophoresis (SPEP) (for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead); OR B.Urine M-protein ≥ 200 mg/24 hours; OR C.If both serum and urine M-protein do not meet the above criteria, an abnormal serum free light chain (FLC) ratio (normal FLC ratio: 0.26 to 1.65) with an involved serum FLC level ≥ 100 mg/L. 4. Accompanied by myeloma-related renal impairment (RI), defined as an estimated glomerular filtration rate (eGFR) \< 40 mL/min (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula). The type of renal impairment must be restricted to cast nephropathy, which can be confirmed by renal biopsy or by the investigator's clinical judgment based on light chain proteinuria. If urine albumin accounts for more than 30% of the total urine protein, a renal biopsy is mandatory to confirm cast nephropathy. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2. 6. Adequate major organ function, meeting the following criteria: A. Hematological function: 1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L, and without receiving granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days, or pegylated G-CSF within 14 days prior to testing; 2. Hemoglobin ≥ 60 g/L, and without receiving whole blood or red blood cell transfusions within 7 days prior to testing; 3. Platelet count ≥ 50 × 10\^9/L, and without receiving whole blood, platelet transfusions, or thrombopoietin receptor agonists (TPO-RAs) within 7 days prior to testing. B. Hepatic function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 × ULN, and total bilirubin ≤ 2 × ULN (subjects with a history of Gilbert's syndrome are eligible if direct bilirubin ≤ 2.0 × ULN). C. Coagulation function: 7. International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. 8. No active concomitant malignancies or malignancies with an expected survival of less than 12 months. 9. Willingness to participate in the study, good compliance, and ability to sign the informed consent form (ICF). Exclusion Criteria: 1. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis, or secondary plasma cell leukemia. 2. Central nervous system (CNS) involvement or clinical evidence of meningeal involvement. 3. Severe and/or uncontrolled cardiac diseases, including: unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, severe and uncontrolled arrhythmias; or other cardiovascular/cerebrovascular diseases deemed unsuitable for study participation by the investigator. 4. Presence of active infections, including: HIV positive; active Hepatitis B (HBV-DNA positive); active Hepatitis C (HCV-RNA positive); active or latent syphilis infection (Treponema pallidum antibody positive); active tuberculosis (active TB infection indicated by chest imaging or other relevant tests within the past 3 months or during the screening period); or other active infections deemed unsuitable for study participation by the investigator. 5. Patients with concurrent malignancies; or severe concomitant diseases that, in the investigator's judgment, would severely compromise patient safety or interfere with study completion. 6. Pregnant or lactating women. 7. History of severe allergic reactions (Grade ≥ 3) or hypersensitivity to any components of the study drugs. 8. Unable or unwilling to sign the informed consent form. 9. Any other conditions that, in the opinion of the investigator, make the patient unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
RECRUITINGTianjin, 300000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple-Drug combo aims to deepen myeloma response before transplant
- Cell therapy targets a marker on myeloma cells
- Oral drug combo targets myeloma that escaped the bone marrow
- Can a Four-Drug combo tame Ultra-High-Risk myeloma?
- MRI scans may reveal hidden clues to myeloma relapse risk
- Can a dual immunotherapy erase hidden myeloma cells?