Multiple MyelomaPhase 2CAREMM-010NCT07830485

CM336 Plus Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma

A Phase 2 study testing CM336 (BCMA/CD3 bispecific antibody), Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Multiple Myeloma
What is being tested?: CM336 (BCMA/CD3 bispecific antibody), Daratumumab and Lenalidomide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 15 Oct 2026to 30 Apr 2031
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 two cycle of anti-myeloma therapy before enrollment are eligible.
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;

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Considered unable to tolerate autologous stem cell transplantation based on investigator assessment.
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).
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.
Adequate renal function, defined as creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault formula.
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%.
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.
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.
Able and willing to receive protocol-recommended prophylactic anticoagulation therapy.
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.

Who cannot join

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.
Severe and/or uncontrolled cardiovascular disease, including:
Unstable angina;
Symptomatic congestive heart failure;

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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.
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;
Concurrent malignancy or any serious concomitant disease that, in the investigator's judgment, could compromise participant safety or interfere with completion of the study.
Pregnant or breastfeeding women.
Expected life expectancy of less than 6 months.
Any active gastrointestinal disorder that may impair the participant's ability to swallow oral medication or may interfere with absorption of study treatment.
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.
Receipt of a live attenuated vaccine within 4 weeks before the first dose of study treatment.
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.
Inability or unwillingness to provide written informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gang An contact

+86 13502181109

angang@ihcams.ac.cn

China1 site

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
Gang An, MD, PhD, +0086 13502181109, angang@ihcams.ac.cn

Other trials in China

About this study

Official title: A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma

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.

Conditions: Multiple Myeloma
Being tested: CM336 (BCMA/CD3 bispecific antibody), Daratumumab, Lenalidomide
Keywords: Transplant-ineligible multiple myeloma, BCMA/CD3 bispecific antibody, CM336, Newly diagnosed multiple myeloma, Minimal residual disease
Medical subject headings: Multiple Myeloma, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CM336 (BCMA/CD3 bispecific antibody)Drug
CM336 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.
DaratumumabDrug
Daratumumab 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.
LenalidomideDrug
Lenalidomide 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.

Study groups in NCT07830485
Study group	Role	What they receive
CM336 plus Dara-R	Experimental	Enrolled participants will receive up to 18 cycles of treatment with CM336 in combination with daratumumab and lenalidomide. Each treatment cycle is 28 days. Receives: Drug: CM336 (BCMA/CD3 bispecific antibody); Drug: Daratumumab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

Minimal residual disease (MRD) negative rate
Proportion of participants achieving minimal residual disease (MRD) negativity after 6 treatment cycles.
Measured: After 6 treatment cycles (each cycle is 28 days)

Secondary outcomes (7)

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.
Measured: From the first dose of CM336 through 30 days after the last dose of CM336, up to approximately 18 months.
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.
Measured: From the first documented MRD-negative assessment until disease progression, death, or end of follow-up, assessed up to approximately 36 months
Overall Response Rate (ORR)
Proportion of participants achieving partial response (PR) or better according to International Myeloma Working Group (IMWG) response criteria.
Measured: Up to 18 treatment cycles (each cycle is 28 days)
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.
Measured: Up to 18 treatment cycles (each cycle is 28 days)
Complete Response Rate (CRR)
Proportion of participants achieving complete response (CR) or stringent complete response (sCR) according to International Myeloma Working Group (IMWG) response criteria.
Measured: Up to 18 treatment cycles (each cycle is 28 days)
Duration of Response (DoR)
Duration of response, defined as the time from the first documented response of partial response (PR) or better until documented disease progression or death from any cause, whichever occurs first.
Measured: From the first documented response until disease progression or death, assessed up to approximately 36 months
Progression-free survival (PFS)
Progression-free survival, defined as the time from the first dose of study treatment until the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the first dose of study treatment until disease progression or death from any cause, assessed up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202630 Apr 2031

First posted21 Sep 2026
Study start15 Oct 2026 (estimated)
Primary completion15 Apr 2029 (estimated)
Study completion30 Apr 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07830485
Sponsor's protocol ID: IIT2026101
Acronym: CAREMM-010
Status last verified: Oct 2026
First submitted: 15 Sep 2026
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Gang An

+86 13502181109

angang@ihcams.ac.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Arm, Single-Center, Phase II Study Evaluating the Safety and Efficacy of CM336 in Combination With Daratumumab and Lenalidomide in Transplant-Ineligible Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT07830485
Acronym / sponsor ID: CAREMM-010 / IIT2026101
Conditions: Multiple Myeloma
Keywords: Transplant-ineligible multiple myeloma, BCMA/CD3 bispecific antibody, CM336, Newly diagnosed multiple myeloma, Minimal residual disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
Study start: 15 Oct 2026 (estimated)
Primary completion: 15 Apr 2029 (estimated)
Study completion: 30 Apr 2031 (estimated)
First posted: 21 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CM336 plus Dara-R	Experimental	Drug: CM336 (BCMA/CD3 bispecific antibody), Drug: Daratumumab, Drug: LenalidomideEnrolled participants will receive up to 18 cycles of treatment with CM336 in combination with daratumumab and lenalidomide. Each treatment cycle is 28 days.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

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 two cycle of anti-myeloma therapy before enrollment are eligible.
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:
Measurable disease, defined by at least one of the following:

Key exclusion criteria (23 listed)

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.
Severe and/or uncontrolled cardiovascular disease, including:
Active infection, including:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CM336 (BCMA/CD3 bispecific antibody)CM336 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.	Drug	CM336 plus Dara-R
DaratumumabDaratumumab 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.	Drug	CM336 plus Dara-R
LenalidomideLenalidomide 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.	Drug	CM336 plus Dara-R

Primary outcome

Minimal residual disease (MRD) negative rate
Time frame: After 6 treatment cycles (each cycle is 28 days)
Proportion of participants achieving minimal residual disease (MRD) negativity after 6 treatment cycles.

7 secondary outcomes

Incidence and severity of adverse events (AEs)
Time frame: From the first dose of CM336 through 30 days after the last dose of CM336, up to approximately 18 months.
Duration of MRD negativity
Time frame: From the first documented MRD-negative assessment until disease progression, death, or end of follow-up, assessed up to approximately 36 months
Overall Response Rate (ORR)
Time frame: Up to 18 treatment cycles (each cycle is 28 days)
Very Good Partial Response or Better Rate (≥VGPR)
Time frame: Up to 18 treatment cycles (each cycle is 28 days)
Complete Response Rate (CRR)
Time frame: Up to 18 treatment cycles (each cycle is 28 days)
Duration of Response (DoR)
Time frame: From the first documented response until disease progression or death, assessed up to approximately 36 months
Progression-free survival (PFS)
Time frame: From the first dose of study treatment until disease progression or death from any cause, assessed up to approximately 36 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Gang An contact

+86 13502181109

angang@ihcams.ac.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gang An (+86 13502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal residual disease (MRD) negative rate (time frame: After 6 treatment cycles (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07830485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.