Study of CM336 in Relapsed or Refractory Multiple Myeloma Patients
ConditionMultiple Myeloma (MM)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeymed Biosciences Co.Ltd
About this trial
The purpose of this study is to compare the efficacy between CM336 and investigator's choice Standard of Care in relapsed or refractory multiple myeloma (RRMM) patients.
Eligibility criteria
Qualifiers
The subjects voluntarily sign the informed consent form (ICF) and agree to abide by the provisions of this protocol.
Age ≥ 18 years old, gender is not limited.
Eastern Cooperative Oncology Group performance status score (ECOG) 0-2 points.
Patients with relapsed or refractory multiple myeloma who have received at least two lines of anti-myeloma treatment previously, and must include at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-Cluster of Differentiation 38(CD38) monoclonal antibody.
Disqualifiers
Previous receipt of any treatment targeting B-cell maturation antigen (BCMA).
Those who are intolerant to dexamethasone will be excluded.
Within 3 months prior to the first administration, they have received chimeric antigen receptor T cells (CAR-T) /chimeric antigen receptor Nature killer cell (CAR-NK) therapy.
Within 3 months prior to the first administration, they have received autologous stem cell transplantation; within 6 months prior to the first administration, they have received allogeneic stem cell transplantation (for subjects who have received allogeneic transplantation, they must have discontinued all immunosuppressants for ≥ 6 weeks and have no signs of graft-versus-host disease before being eligible for enrollment).
Trial design
Treatments tested in this trial
- CM336 Injection
- Standard Of Care( SOC)
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov