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High Risk Smoldering Multiple MyelomaNCT06745687

BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma

A study testing CM336 in people with High Risk Smoldering Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA/CD3 BiTE, in the treatment of high risk smoldering multiple myeloma. Read more about this study

Who is it for?
Ages 18 to 78 yearsHealthy volunteers can take part
Conditions the study is for
High Risk Smoldering Multiple Myeloma
What is being tested?
CM336
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
30 Dec 2024to 1 Aug 2029
Phase
Interventional
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 78 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Know and voluntarily sign an informed consent form (ICF).
  • Age ≥18 years.
  • Definite diagnosis of SMM: According to IMWG Criteria 10, the patient must have histologically or cytologically confirmed smoldering multiple myeloma (SMM), including:
  • Serum M protein ≥3 g /dL and/or BMPCs≥10%(but not more than 60%)
  • No anemia: hemoglobin ≥10 g /dL
  • No renal failure: serum creatinine ≥2.0 mg/dL
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  • No hypercalcemia: calcium ≥10.5 mg/dL
  • dissolving bone lesions without radiographic indications: X-ray, CT, or positron emission tomography (PET)/CT without dissolving bone lesions, with no more than 1 lesion on whole-body MRI (Note: In the investigator's judgment, whole-body CT or PET/CT may replace MRI for patients with contraindications or for whom MRI is not available).
  • FLC ratio <100 (unless light chain ≤10 mg /dL is involved) Note: Anemia, renal failure and hypercalcemia are allowed if there is evidence that anemia, renal failure, hypercalcemia or bone lesions are not associated with multiple myeloma (MM).
  • High-risk SMM are defined as meeting one or more of the three criteria in the following part: (i) Mayo 2018, (ii) IMWG 2020 and (iii) evolving pattern.
  • (i)Mayo 2018
  • M protein > 2 g/dL ② The ratio of affected to unaffected FLC was > 20 ③BMPC > 20% of the 3 items meet any 2 or more
  • IMWG 2020
  • FLC ratio 0-10: 0 points 10-25: 2 points 25-40: 3 points >40: 5 points
  • ②M protein (g/dL) 0-1.5: indicates 0 points 1.5-3: 3 points >3: 4 points
  • ③BMPC (%) 0-15: 0 points 15-20: 2 points 20-30: 3 points 30-40: 5 points >40: 6 points
  • ④FISH : Yes: 2 points None: 0 points The sum of the four points is greater than or equal to 9 （iii）Progression model
  • Necessary condition: BMPC>10% ② Sufficient conditions: a. Serum M protein >3 g/dL b. IgA type SMM c. Immune paralysis (reduction of two uninvolved homologous immunoglobulins) d. The proportion of free light chain (FLC) in serum that is affected/not affected > 8 (but <100) e.M protein level increased (SMM type increased; Serum M protein level was increased by ≥25% twice in 6 months.
  • F.BMPC: 50%-59% g. Abnormal plasma cell immunophenotype (95% + of cloned BMPC) and reduction of one or more uninvolved immunoglobulin types.
  • h.≥5% of cells had chromosomal abnormalities (t (4,14) or del 17 p or 1 q acquisition i. Increased circulating plasma cells (PCs>5×106/L or 5%) j. Merri indicates diffuse abnormalities or 1 focal lesion, and/or increased uptake of focal lesion in PET-CT class without underlying osteolytic osteopathy. Meet the necessary conditions, 1 or more sufficient conditions.
  • FISH exceptions are defined as the presence of any of the following: t (4,14), t (14,16), 1 q amplification, del 13 qt, t (4,20)
  • ECOG physical status score ≤2 points.
  • Meeting the following laboratory indicators within 28 days prior to study participation:
  • neutrophils absolute value (ANC) >1000/ml b. Platelet count (PLC)> 75,000 /ml c. Total bilirubin ≤2 mg/dL d. Glutamic oxalic aminotransferase (AST) <2.5 times the conventional upper limit (ULN) e. Alanine aminotransferase (ALT) <2.5 times the upper limit of normal (ULN) f. Estimated creatinine clearance (CLcr)≥60 mL/min.
  • Non-childbearing women meet the entry requirements; Female patients of childbearing age must have a negative serum (beta-human chorionic gonadotropin) or urine pregnancy test at the time of screening.
  • Men, women of childbearing age, and their partners voluntarily use contraception deemed effective by investigators during treatment and for at least three months after CAR T cell transfusion.
  • Male patients must agree not to donate sperm from the initial screening period until 90 days after the last medication.
  • Patients must be willing and able to complete study procedures and follow-up examinations.
  • Note: Fertile women are all women who have begun menstruating and are not in late menopause and who have not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as more than 12 consecutive months of amenorrhea for an unspecified reason. Women who are using mechanical birth control methods such as oral contraceptives or intrauterine devices should be considered fertile. Male subjects (including those who have undergone vasectomy) must consent to the use of condoms during sex with women of childbearing age and must not plan to impregnate the woman during the study drug use period from the date of signing the informed consent form and within 3 months after the last study drug receipt.

Who cannot join

  • Diagnosis of symptomatic multiple myeloma: refer to the Chinese Guidelines for Diagnosis and Treatment of multiple myeloma (revised in 2022);
  • Along with other tumors that must be treated.
  • Previously received immunotherapy against BCMA targets.
  • The researchers judged that BCMA/CD 3 dual antibody therapy is not suitable, such as severe cardiopulmonary disease and other conditions that are not suitable for BCMA/CD 3 dual antibody therapy.
  • Received SMM treatment within six months.
  • Known intolerance, allergy or contraindications to BCMA/CD 3 dual anti-active ingredients.
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  • Patients with unstable or active cardiovascular and cerebrovascular diseases meet any of the following criteria:
  • Unstable angina pectoris, symptomatic myocardial ischemia, myocardial infarction, or coronary artery reconstruction had occurred within 180 days prior to initial administration.
  • Uncontrolled hypertension (>140/90 MMHG, with a blood pressure fluctuation of more than 180/100 MMHG over 6 months);
  • Uncontrolled and clinically significant conduction abnormalities (e.g., patients with ventricular arrhythmias controlled by antiarrhythmic drug therapy), not excluding patients with first-degree AV block or asymptomatic left anterior bundle branch block/right bundle branch block (LAFB/RBBB);
  • Echocardiographic left ventricular ejection fraction (LVEF) < 40%;
  • History of stroke or intracranial hemorrhage within 12 months prior to screening;
  • Severe thrombotic events before treatment.
  • 9) Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
  • 10) Active hepatitis B or C infection. Screening requires hepatitis serological testing. If hepatitis B surface antigen is positive, a negative DNA polymerase chain reaction (PCR) result is required to be confirmed before enrollment (after anti-HBV treatment, a negative DNA polymerase PCR result is required before enrollment). If the hepatitis C antibody is positive, an RNA PCR test is performed and the result before enrollment is confirmed to be negative.
  • 11) Pregnant or lactating women. 12) Any active gastrointestinal dysfunction that affects the patient's ability to swallow pills, or any active gastrointestinal dysfunction that may affect the absorption of investigational therapeutic drugs.
  • 13) Patients had major surgery (for example, requiring general anesthesia) within 2 weeks before enrollment began, or will not fully recover from surgery, or have surgery scheduled during the time they plan to participate in the study. Kyphoplasty or spondyloplasty is not considered major surgery. Note: Patients who plan to perform surgery under local anesthesia may participate in the study.
  • 14) Received live attenuated vaccine within 4 weeks prior to administration of the first investigational drug.

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, MD, PhD contact

+86 022-23909171

angang@ihcams.ac.cn

jieqiong zhou, MBBS contact

008617827063445

zhoujieqiong@ihcams.ac.cn

China1 site, 1 recruiting

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

    Tianjin

    Gang An, MD&PhD, +86-022-23909171, angang@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multi-center, Single-arm Clinical Trial of BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma

The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA/CD3 BiTE, in the treatment of high risk smoldering multiple myeloma.

Read the detailed description

The purpose of this study is to evaluate the safety and efficacy of CM-336, which is a BCMA/CD3 BiTE, in the treatment of high risk smoldering multiple myeloma.

High-risk SMM has a high risk of transforming to MM, and there is no unified treatment plan in clinical practice at present. Studies have proved that early treatment can help prevent end organ damage caused by disease progression and improve patient prognosis. The treatment of high-risk SMM needs to be further explored. BCMA/CD3 BITE in the treatment of RRMM shows a high remission rate and low toxicity and side effects, and it is expected to become a potential treatment choice for high-risk SMM patients

Being tested
CM336
Keywords
high risk smoldering multiple myeloma, BCMA/CD3 BiTE, CM-336

What participants receive

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

  • CM336Drug

    Patients received subcutaneous CM-336 80 mg once weekly in 28-d cycles after two step-up priming doses of 3 mg and 20 mg given on day 1 and day 4 of cycle 1 and cycle2. Then patients will be given 160mg every 2 weeks from cycle 3 to cycle 6. The dosing interval is adjusted according to the evaluation of efficacy every 6 cycles from cycle 7 to cycle 24.

Study groups in NCT06745687
Study groupRoleWhat they receive
CM-336( BCMA/CD3 bispecific antibody)ExperimentalPatients enrolled in the trial will receive CM336 subcutaneously, which is an BCMA/CD3 bispecific antibody therapy.
Receives: Drug: CM336

What is being measured

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

  1. minimal residual disease netativity(MRD negativity)

    The proportion of abnormal plasma cells occupying nuclear cells in the samples

    Measured: baseline, 28 days per cycle, cycle 6 day 28, cycle 12 day 28, cycle 18 day 28, cycle 24 day 28, 1 year and 2 year after end of treatment.

Secondary outcomes (6)

  1. time to response

    Time from randomization to first documentation of hematologic response

    Measured: up to 2 years

  2. Hematologic response rate

    Overall hematologic (CR + VGPR + PR) response rate based on central laboratory results based on 2016 IMWG response criteria.

    Measured: up to 2 years

  3. Adverse events and serious adverse events

    Adverse events (AEs), serious adverse events (SAEs), and assessments of clinical laboratory values

    Measured: up to 2 years

  4. progression free survival(PFS)

    progression free survival defined as time from randomization to date of hematologic progression or documented disease progression (PD). Patients without documentation of death at the time of analysis were censored at the date last known to be alive

    Measured: up to 2 years after end of therapy

  5. overall survival(OS)

    Time from randomization to date of death. Patients without documentation of death at the time of analysis were censored at the date last known to be alive

    Measured: up to 2 years after end of therapy.

  6. duration of response(DOR)

    DOR is defined as the time from initiation of first response to first documentation of disease progression or death whichever occurs first. Patients without documentation progressed or died are censored at the date last known progression-free.

    Measured: up to 2 years after end of therapy

Timeline

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

  1. First posted20 Dec 2024
  2. Study start30 Dec 2024
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2029 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single-arm multi-center trial
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06745687
Sponsor's protocol ID
IIT2024009
Status last verified
Jul 2026
First submitted
10 Dec 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CM336 in people with High Risk Smoldering Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in 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 29 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 23 Jul 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.

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, MD, PhD (+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 netativity(MRD negativity) (time frame: baseline, 28 days per cycle, cycle 6 day 28, cycle 12 day 28, cycle 18 day 28, cycle 24 day 28, 1 year and 2 year after end of treatment.). 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 NCT06745687.

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 23 Jul 2026.

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