Bispecific antibody combo aims to deepen myeloma responses

NCT ID NCT07830485

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether CM336, a bispecific antibody that helps the immune system target myeloma cells, works safely and effectively when combined with daratumumab and lenalidomide. The trial enrolls adults aged 18 to 75 with newly diagnosed multiple myeloma who are not planned for a stem cell transplant. All participants receive the combination in 28-day cycles, with regular blood tests and bone marrow checks to track response and side effects. The main goal is to see how many participants have no detectable cancer cells left after six cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CM336, an experimental bispecific antibody that helps the immune system attack myeloma cells, given with daratumumab and lenalidomide
What this could lead to
If it works, this combination could offer a treatment option for older adults with newly diagnosed multiple myeloma who cannot have a stem cell transplant.
What could go wrong
This is a small, single-arm phase 2 trial with no comparison group, so it cannot prove the combination is better than standard care. Bispecific antibodies can cause serious immune reactions and infections.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to understand and voluntarily sign a written informed consent form (ICF). 2. Age 18 to 75 years. 3. 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. 4. Not planned to undergo autologous stem cell transplantation as first-line treatment and meeting at least one of the following criteria, including but not limited to: * Age ≥65 years; * Eastern Cooperative Oncology Group (ECOG) performance status of 3-4; * Considered unable to tolerate autologous stem cell transplantation based on investigator assessment. 5. Measurable disease, defined by at least one of the following: * Serum M-protein ≥10 g/L by serum protein electrophoresis (SPEP); for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead; * Urine M-protein ≥200 mg/24 hours; * If neither serum nor urine M-protein meets the above criteria, involved serum free light chain (FLC) ≥100 mg/L with an abnormal serum FLC ratio (normal range: 0.26-1.65). 6. Adequate hepatic function, defined as: * Total bilirubin \<1.5 × upper limit of normal (ULN), except for participants with Gilbert syndrome, who must have total bilirubin \<3 × ULN; * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN. 7. Adequate renal function, defined as creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault formula. 8. Hematologic parameters within 7 days prior to screening meeting the following criteria: * White blood cell (WBC) count ≥1.5 × 10\^9/L; * Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L; * Hemoglobin ≥70 g/L; * Platelet count ≥75 × 10\^9/L if bone marrow plasma cells are \<50%, or ≥50 × 10\^9/L if bone marrow plasma cells are ≥50%. 9. Participants receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or thrombopoietic agents (e.g., eltrombopag, thrombopoietin, or interleukin-11), must have an interval of at least 2 weeks between the last administration of growth factor support and screening assessment. 10. Participants receiving blood product transfusions must meet the following requirements: * At least 2 weeks between the last red blood cell (RBC) transfusion and hemoglobin assessment at screening; * At least 1 week between the last platelet transfusion and platelet assessment at screening. 11. Able and willing to receive protocol-recommended prophylactic anticoagulation therapy. 12. Female participants of childbearing potential must: * Have a negative serum pregnancy test at screening; and * Agree to use effective contraception from the date of signing informed consent throughout study treatment and for at least 3 months after the last dose of study treatment. Male participants, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must not plan to father a child from the date of signing informed consent throughout study treatment and for at least 3 months after the last dose of study treatment. Exclusion Criteria: 1. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary or secondary plasma cell leukemia. 2. Central nervous system (CNS) involvement or clinical evidence of leptomeningeal involvement. 3. Known intolerance, hypersensitivity, allergy, or contraindication to daratumumab, lenalidomide, or CM336. 4. Severe and/or uncontrolled cardiovascular disease, including: * Unstable angina; * Symptomatic congestive heart failure; * Myocardial infarction within 6 months prior to enrollment; * Severe and uncontrolled cardiac arrhythmias; * Any other cardiovascular or cerebrovascular condition deemed by the investigator to make participation inappropriate. 5. Active infection, including: * Human immunodeficiency virus (HIV) infection; * Active hepatitis B infection (HBV DNA positive); * Active hepatitis C infection (HCV RNA positive); * Active or latent syphilis infection (Treponema pallidum antibody positive); * Active pulmonary tuberculosis, as evidenced by chest imaging or other relevant examinations within 3 months before screening or during the screening period; 6. Concurrent malignancy or any serious concomitant disease that, in the investigator's judgment, could compromise participant safety or interfere with completion of the study. 7. Pregnant or breastfeeding women. 8. Expected life expectancy of less than 6 months. 9. Any active gastrointestinal disorder that may impair the participant's ability to swallow oral medication or may interfere with absorption of study treatment. 10. Major surgery within 2 weeks prior to enrollment (e.g., surgery requiring general anesthesia), incomplete recovery from prior surgery, or planned major surgery during study participation. Kyphoplasty and vertebroplasty are not considered major surgery. Participants undergoing procedures under local anesthesia may be eligible. 11. Receipt of a live attenuated vaccine within 4 weeks before the first dose of study treatment. 12. Any active severe psychiatric disorder, medical condition, symptom, or other circumstance that, in the investigator's judgment, may interfere with treatment, protocol compliance, or the ability to provide informed consent. 13. Inability or unwillingness to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

Neoplasm, Residual plasma cell myeloma

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300000, China

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