Not Yet RecruitingPhase 2

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

20 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Be able to understand and voluntarily signs the informed consent form (ICF).
✓. Age ≥ 18 years.
✓. Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
✓. MRD positivity (≥10-⁵) detected by EuroFlow.
✓. 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.
✓. 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).
✓. No prior maintenance therapy.
✓. Achieved at least a partial response (≥PR) according to the IMWG 2016 response criteria.

Exclusion criteria

✕. Prior treatment with genetically modified adoptive cellular therapy.
✕. History of allogeneic stem cell transplantation or solid organ transplantation.
✕. 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.
✕. Central nervous system involvement.

What they're measuring

Minimal residual disease (MRD) negativity conversion rate

Timeframe: Up to 24 months

Trial details

NCT IDNCT07409454

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

An Gang, PhD&MD

86-022-23909171 angang@ihcams.ac.cn

View on ClinicalTrials.gov More Multiple Myeloma trials