BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-78
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Know and voluntarily sign an informed consent form (ICF).
Age ≥18 years.
Serum M protein ≥3 g /dL and/or BMPCs≥10%(but not more than 60%)
No anemia: hemoglobin ≥10 g /dL
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CM336
DrugPatients 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CM-336( BCMA/CD3 bispecific antibody)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
minimal residual disease netativity(MRD negativity)
The proportion of abnormal plasma cells occupying nuclear cells in the samples
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.Secondary outcomes
1
time to response
Time from randomization to first documentation of hematologic response
Time frame
up to 2 years2
Hematologic response rate
Overall hematologic (CR + VGPR + PR) response rate based on central laboratory results based on 2016 IMWG response criteria.
Time frame
up to 2 years3
Adverse events and serious adverse events
Adverse events (AEs), serious adverse events (SAEs), and assessments of clinical laboratory values
Time frame
up to 2 years4
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
Time frame
up to 2 years after end of therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Keymed Biosciences Co.Ltd
Collaborator
Source ClinicalTrials.gov