This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed/refractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.
Tumor response will be evaluated according to the International Myeloma Working Group (IMWG) uniform response criteria (2016). Assessments will be performed at baseline, and then at Day 28 post-infusion, Month 2, Month 3, and subsequently every 3 months from Month 3 to Month 24, until the subject completes the 24-month follow-up period, experiences disease progression (PD)/relapse, initiates new anti-tumor therapy, dies, or withdraws from the study, whichever occurs first.
Age: Aged 18 to 80 years (inclusive), of either sex.
Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Diagnosed with relapsed/refractory multiple myeloma according to the IMWG criteria, who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent-based regimen).
Reproductive Status: Subjects of childbearing potential and their partners must agree to use medically accepted highly effective contraceptive methods (e.g., intrauterine device, condom) from the time of signing the informed consent form until 12 months after the last dose. They must not donate germ cells, including sperm or oocytes, during this period.
Pregnancy/Lactation: Women who are pregnant or breastfeeding.
Other Malignancies: Subjects with a prior or concurrent other malignancy.
Infectious Diseases: Positive for human immunodeficiency virus (HIV) antibody; active hepatitis B virus infection (HBV-DNA > 10³ IU/mL); acute or chronic active hepatitis C (HCV antibody positive); positive syphilis antibody; cytomegalovirus (CMV) infection (IgM positive or DNA positive).
Presence of clinically active uncontrolled infection based on assessment done by treating physicians.
Single group
IMV102 treatment
Biological/VaccineEligible patients with relapsed/refractory multiple myeloma will receive an infusion of IMV102 injection, and the safety and efficacy of IMV102 injection will be evaluated within 24 months post-infusion.
To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma
Incidence of adverse events and its severity after IMV102 injection treatment
Assessment of pharmacokinetic (about Cmax)
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
Assessment of pharmacokinetic (about Tmax)
The time to reach the maximum concentration (Tmax)
Assessment of pharmacokinetic (about AUC0-28d)
The area under the CAR-T concentration versus time curve (AUC) for 28 days after IMV102 administration
Assessment of pharmacokinetic (about AUC0-90d)
The area under the CAR-T concentration versus time curve (AUC) for 90 days after IMV102 administration
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