BCMA/CD3 BsAb in the Treatment of High-risk Smoldering Multiple Myeloma
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- CM336
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Keymed Biosciences Co.Ltd
Collaborator
Source ClinicalTrials.gov