anti-BCMA/CD3 bispecific antibody: Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
Minimal residual disease (MRD) negativity conversion rate — Up to 24 months
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
China
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.