NCT07409454 MRD-Guided BCMA/CD3 Bispecific Antibody Treatment After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma
| NCT ID | NCT07409454 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-07-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-07-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07409454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07409454 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07409454 currently recruiting?
Yes, NCT07409454 is actively recruiting participants. Contact the research team at angang@ihcams.ac.cn for enrollment information.
Where is the NCT07409454 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07409454 clinical trial?
NCT07409454 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 20 participants.