MRD-Guided BCMA/CD3 Bispecific Antibody Treatment After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: anti-BCMA/CD3 bispecific antibody.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Single-Arm Clinical Trial of MRD-Guided BCMA/CD3 Bispecific Antibody as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma
Overview
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.
Interventions
- Drug anti-BCMA/CD3 bispecific antibody
Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).
Primary outcome measures
- Minimal residual disease (MRD) negativity conversion rate [Time frame: Up to 24 months]
Secondary outcome measures (4)
- Duration of MRD negativity [Time frame: Up to 24 months]
- Progression-Free Survival [Time frame: From enrollment to the date of disease progression or death, up to approximately 24 months.]
- Overall Survival (OS) [Time frame: From start of treatment until death from any caus, up to approximately 24 months.]
- Incidence and severity of adverse events (AEs) [Time frame: From the first dose through 30 days after the last dose, up to approximately 24 months.]
Eligibility criteria
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.
- Presence of measurable disease at diagnosis.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07409454 · IIT2025139