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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • anti-BCMA/CD3 bispecific antibody

Treatment groups

20 Participants
are divided into 1 treatment group