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Clinical Trials in China / NCT07409454
Recruiting Phase 2

MRD-Guided BCMA/CD3 Bispecific Antibody Treatment After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma

NCT07409454 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2026-07-07
Last updated
2026-08-07

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

anti-BCMA/CD3 bispecific antibody →

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)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tianjin China Recruiting

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Official registry record

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.

View NCT07409454 on ClinicalTrials.gov ↗ ← All trials in China