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

NCT07409454 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2025139
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma

Keywords

BCMA/CD3 bispecific antibody; multiple myeloma; CM336

Outcome Measures

Primary Outcomes (1)

• Minimal residual disease (MRD) negativity conversion rate

  Up to 24 months

Secondary Outcomes (4)

• Duration of MRD negativity

  Up to 24 months

• Progression-Free Survival

  From enrollment to the date of disease progression or death, up to approximately 24 months.

• Overall Survival (OS)

  From start of treatment until death from any caus, up to approximately 24 months.

• Incidence and severity of adverse events (AEs)

  From the first dose through 30 days after the last dose, up to approximately 24 months.

Study Arms (1)

BsAbs-treatment group

EXPERIMENTAL

Drug: anti-BCMA/CD3 bispecific antibody

Interventions

anti-BCMA/CD3 bispecific antibody DRUG

Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).

BsAbs-treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

An Gang, PhD&MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share