Multiple MyelomaPhase 2CAREMM-013NCT07648459
CM336-SOC for Dynamically High-Risk Multiple Myeloma Study
A Phase 2 study testing anti-BCMA/CD3 bispecific antibody in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a single-arm, open-label study to evaluate the efficacy and safety of CM336 combined with SOC therapy in patients with dynamically high-risk multiple myeloma. 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?
- anti-BCMA/CD3 bispecific antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jul 2028
- 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 the informed consent form (ICF).
- Aged ≥18 and ≤75 years.
- Has measurable disease, meeting at least one of the following criteria: serum M-protein ≥5 g/L as measured by serum protein electrophoresis (SPEP); or, for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead; or 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 in the presence of an abnormal serum FLC ratio (normal FLC ratio: 0.26 to 1.65).
- Has received only one prior line of standard anti-myeloma therapy: standard induction therapy comprising at least two of the following: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; followed by autologous hematopoietic stem cell transplantation or consolidation therapy, and standard maintenance therapy.
- Meets the definition of functional high-risk multiple myeloma according to the EMN consensus: disease progression or relapse within 18 months after initiation of any first-line therapy.
- Liver function tests meet the following criteria: total bilirubin <1.5 × upper limit of normal (ULN) (except that patients with Gilbert's syndrome must have total bilirubin <3 × ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN.
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- Renal function tests meet the following criterion: creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
- Complete blood count within 7 days before screening meets the following criteria: white blood cell (WBC) count ≥1.5 × 10⁹/L, absolute neutrophil count ≥1.0 × 10⁹/L, hemoglobin ≥70 g/L, and platelet count ≥75 × 10⁹/L if bone marrow plasma cells are <50%, or platelet count ≥50 × 10⁹/L if bone marrow plasma cells are ≥50%; or, in the investigator's judgment based on the actual clinical situation, the subject is considered suitable for enrollment.
- For patients receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and platelet agonists, etc. (e.g., eltrombopag, TPO, interleukin-11), there must be an interval of 2 weeks between growth factor support and screening assessment.
- For patients receiving blood product transfusions: there must be an interval of at least 2 weeks between the screening hemoglobin assessment and the last red blood cell (RBC) transfusion, and an interval of at least 1 week between the screening platelet assessment and the last platelet transfusion.
- The subject is able to receive the prophylactic anticoagulation recommended in the study.
- Female subjects of childbearing potential must meet both of the following conditions: agree to use effective contraception from the date of signing the informed consent form, during treatment with the study drug, and for 3 months after the last dose of the study drug; and have a negative serum pregnancy test result at screening.
Who cannot join
- Primary plasma cell leukemia or secondary plasma cell leukemia.
- Concurrent amyloidosis.
- Concurrent central nervous system (CNS) involvement.
- Prior treatment with BCMA-targeted therapy or CAR-T cell therapy.
- Known intolerance, allergy, or contraindication to glucocorticoids or BCMA/CD3 bispecific antibody products.
- Clinically significant cardiac disease, including: myocardial infarction before randomization; or unstable or uncontrolled disease related to or affecting cardiac function, such as unstable angina, congestive heart failure, or New York Heart Association class III-IV cardiac function. Uncontrolled arrhythmia or clinically significant ECG abnormalities. Baseline corrected QT interval (QTc) >470 msec on 12-lead ECG at screening.
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- Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
- Active hepatitis B or C infection. Hepatitis serology testing is required at screening. If hepatitis B surface antigen or hepatitis B core antibody is positive, a negative DNA polymerase chain reaction (PCR) result must be confirmed before enrollment; for patients receiving anti-hepatitis B antiviral therapy, a negative DNA PCR result must be confirmed before enrollment. If hepatitis C antibody is positive, RNA PCR testing must be performed, and a negative result must be confirmed before enrollment.
- Pregnant or breastfeeding women.
- Life expectancy <6 months.
- Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect absorption of the study treatment.
- Major surgery within 2 weeks before the start of randomization, such as surgery requiring general anesthesia; incomplete recovery from surgery; or planned surgery during the study period. Kyphoplasty or vertebroplasty is not considered major surgery.
- Note: Subjects scheduled to undergo surgical procedures under local anesthesia may participate in the study.
- Receipt of a live attenuated vaccine within 4 weeks before the first dose of study drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-Arm, Single-Center, Phase II Clinical Study of CM336 Combined With SOC Therapy in Patients With Dynamically High-Risk Multiple Myeloma
This is a single-arm, open-label study to evaluate the efficacy and safety of CM336 combined with SOC therapy in patients with dynamically high-risk multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- anti-BCMA/CD3 bispecific antibody
- Keywords
- BCMA/CD3 bispecific antibody, multiple myeloma, CM336
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-BCMA/CD3 bispecific antibodyDrug
Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).
| Study group | Role | What they receive |
|---|---|---|
| BsAbs-treatment group | Experimental | Not described Receives: Drug: anti-BCMA/CD3 bispecific antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease (MRD) negativity rate
Measured: 12 months
Secondary outcomes (6)
Adverse events and serious adverse events
Measured: Up to 2 year
Sustained MRD negativity rate
Measured: Up to 2 year
Overall response rate (ORR)
Measured: Up to 2 year
Complete response rate (CR)
Measured: Up to 2 year
Duration of response (DoR)
Measured: Up to 2 year
Progression-free survival (PFS)
Measured: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion9 Jul 2027 (estimated)
- Study completion30 Jul 2028 (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.
- 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648459
- Sponsor's protocol ID
- IIT2026054
- Acronym
- CAREMM-013
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Single-Center, Phase II Clinical Study of CM336 Combined With SOC Therapy in Patients With Dynamically High-Risk Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07648459
- Acronym / sponsor ID
- CAREMM-013 / IIT2026054
- Conditions
- Multiple Myeloma
- Keywords
- BCMA/CD3 bispecific antibody, multiple myeloma, CM336
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 15 Jun 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.
This is a single-arm, open-label study to evaluate the efficacy and safety of CM336 combined with SOC therapy in patients with dynamically high-risk multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BsAbs-treatment group | Experimental | Drug: anti-BCMA/CD3 bispecific antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to understand and voluntarily sign the informed consent form (ICF).
- Aged ≥18 and ≤75 years.
- Has measurable disease, meeting at least one of the following criteria: serum M-protein ≥5 g/L as measured by serum protein electrophoresis (SPEP); or, for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead; or 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 in the presence of an abnormal serum FLC ratio (normal FLC ratio: 0.26 to 1.65).
- Has received only one prior line of standard anti-myeloma therapy: standard induction therapy comprising at least two of the following: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; followed by autologous hematopoietic stem cell transplantation or consolidation therapy, and standard maintenance therapy.
- Meets the definition of functional high-risk multiple myeloma according to the EMN consensus: disease progression or relapse within 18 months after initiation of any first-line therapy.
Key exclusion criteria (14 listed)
- Primary plasma cell leukemia or secondary plasma cell leukemia.
- Concurrent amyloidosis.
- Concurrent central nervous system (CNS) involvement.
- Prior treatment with BCMA-targeted therapy or CAR-T cell therapy.
- Known intolerance, allergy, or contraindication to glucocorticoids or BCMA/CD3 bispecific antibody products.
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 |
|---|---|---|
| anti-BCMA/CD3 bispecific antibodyAnti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC). | Drug | BsAbs-treatment group |
Primary outcome
Minimal residual disease (MRD) negativity rate
Time frame: 12 months
6 secondary outcomes
Adverse events and serious adverse events
Time frame: Up to 2 year
Sustained MRD negativity rate
Time frame: Up to 2 year
Overall response rate (ORR)
Time frame: Up to 2 year
Complete response rate (CR)
Time frame: Up to 2 year
Duration of response (DoR)
Time frame: Up to 2 year
Progression-free survival (PFS)
Time frame: From the first dose of study treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 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 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-BCMA/CD3 bispecific antibody in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China.
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 12 inclusion and 14 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (86-022-23909171, 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) negativity rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.