MRD-guided BCMA/CD3 bispecific antibody after stem cell transplant in newly diagnosed myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single-arm trial evaluating CM336 as maintenance therapy after autologous stem cell transplantation in adults with newly diagnosed multiple myeloma. Eligible participants have MRD positivity and completed first-line therapy including an ASCT, with no prior maintenance therapy. The study will monitor safety and how well the drug maintains or improves disease response. Enrollment is at a single center in Tianjin, China, led by the Institute of Hematology & Blood Diseases Hospital, with no listed collaborators. The intervention targets BCMA/CD3 with the aim of controlling disease while minimizing adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: An Gang, PhD&MD
• Email: angang@ihcams.ac.cn
• Phone: 86-022-23909171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.