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

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT07409454

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

20

Starts

2026-07-07

Expected to finish

2028-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Presence of measurable disease at diagnosis.

You may not qualify if…

• 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.

Where it is running

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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