This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.
Be informed and voluntarily sign the Informed Consent Form (ICF).
Age ≥18 years.
Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
Subjects with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of therapy. Extramedullary disease (EMD) is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions. The maximum diameter of extramedullary lesions should ≥2cm detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy.
Plasma cell leukemia or solitary plasmacytoma.
Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for enrollment).
Evidence of primary or secondary resistance to elotuzumab, carfilzomib, or thalidomide.
Pregnant or breastfeeding women, or women with pregnancy plans within the next six months.
Single group
anti-BCMA/GPRC5D bispecific CAR-T
Biological/VaccineAutologous BCMA/GPRC5D bispecific CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA/GPRC5D bispecific CAR-T cells/kg.
Apornemin
DrugApornemin 10mg/kg will be administered by i.v. infusion. Apornemin will be administered on Days 1-5, 15-19 during bridging therapy, and on Days 1-5 every 28-day cycle during maintanance treatment.
Carfilzomib
DrugCarfilzomib 27mg/m\^2 will be administered by i.v. on Days 1,2,8,9 during bridging therapy.
Thalidomide
DrugThalidomide (150mg/d) will be administered by p.o. on Days 1-14 during bridging therapy, and Days 1-28 every 28-day cycle during maintanance treatment.
Dexamethasone
DrugDexamethasone (20mg/d) will be administered by i.v. or p.o. on Days 1-4,8,9 during bridging therapy.
Overall response rate (ORR)
The definition of ORR is the proportion of participants who achieve a PR or better as the best response according to the IMWG criteria.
ORR before CAR-T cell infusion
ORR before CAR-T cell infusion is defined as the proportion of participants who achieve a confirmed PR or better as the best response after conditioning treatment but prior to CAR-T cell infusion.
Progression free survival(PFS)
Progression free survival is defined as the time from the start of Aponermin treatment to disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the start of Aponermin treatment to the date of the participant's death.
Adverse events and serious adverse events
Adverse events (AEs), serious adverse events (SAEs), and assessments of clinical laboratory values
Click on the lead sponsor to view all of their trials.
