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New treatment option for High Risk Smoldering Multiple Myeloma
Official title BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma
ClinicalTrials.gov ID: NCT06745687
What this study is testing
What is CM336?
CM336 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for high risk smoldering multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 78. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Serum M protein ≥3 g /dL and/or BMPCs≥10%(but not more than 60%)
- No anemia: hemoglobin ≥10 g /dL
You likely can't join if
- 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...
- Received SMM treatment within six months.
- Known intolerance, allergy or contraindications to BCMA/CD 3 dual anti-active ingredients.
See the full eligibility criteria
- 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
- 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...
- 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...
- 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 (ii) 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...
- 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...
- ECOG physical status score ≤2 points.
- Meeting the following laboratory indicators within 28 days prior to study participation: a. neutrophils absolute value (ANC) \>1000/ml b. Platelet count (PLC)\> 75,000 /ml c. Total bilirubin ≤2 mg/dL d. Glutamic oxalic...
- 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 78 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.