Multiple Myeloma
Conditions
Keywords
BCMA/CD3 bispecific antibody, multiple myeloma, CM336
Brief summary
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of the BCMA/CD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.
Interventions
Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be able to understand and voluntarily signs the informed consent form (ICF). 2. Age ≥ 18 years. 3. Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria. 4. MRD positivity (≥10-⁵) detected by EuroFlow. 5. Previous therapy limited to first-line treatment only, including: (1) Induction therapy with a 3- or 4-drug regimen containing a proteasome inhibitor and/or an immunomodulatory drug and/or an anti-CD38 monoclonal antibody; (2) Single or tandem autologous stem cell transplantation (ASCT); (3) Up to 2-4 cycles of consolidation therapy post-ASCT are permitted, with the total number of induction plus consolidation cycles not exceeding 8. 6. Completion of ASCT within ≤12 months from the start of induction therapy; and ≤6 months from the most recent ASCT at enrollment (≤7 months if consolidation therapy was administered). 7. No prior maintenance therapy. 8. Achieved at least a partial response (≥PR) according to the IMWG 2016 response criteria. 9. Presence of measurable disease at diagnosis.
Exclusion criteria
1. Prior treatment with genetically modified adoptive cellular therapy. 2. History of allogeneic stem cell transplantation or solid organ transplantation. 3. Disease progression prior to enrollment (per IMWG 2016 response criteria), or presence of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or light-chain amyloidosis not attributable to symptomatic multiple myeloma. 4. Central nervous system involvement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal residual disease (MRD) negativity conversion rate | Up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of MRD negativity | Up to 24 months |
| Progression-Free Survival | From enrollment to the date of disease progression or death, up to approximately 24 months. |
| Overall Survival (OS) | From start of treatment until death from any caus, up to approximately 24 months. |
| Incidence and severity of adverse events (AEs) | From the first dose through 30 days after the last dose, up to approximately 24 months. |
Countries
China
Contacts
CONTACTAn Gang, PhD&MD
Outcome results
None listed