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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Eligible 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.
Beijing GoBroad Boren Hospital
Beijing, China
RECRUITINGThe second affiliated hospital of Chongqing medical university
Chongqing, China
NOT_YET_RECRUITINGRenji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
NOT_YET_RECRUITINGZhengzhou Yihe Hospital
Zhengzhou, China
NOT_YET_RECRUITINGTo evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma
Incidence of adverse events and its severity after IMV102 injection treatment
Time frame: 24 months post IMV102 infusion
Assessment of pharmacokinetic (about Cmax)
The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax)
Time frame: 24 months post IMV102 infusion
Assessment of pharmacokinetic (about Tmax)
The time to reach the maximum concentration (Tmax)
Time frame: 24 months post IMV102 infusion
Assessment of pharmacokinetic (about AUC0-28d)
The area under the CAR-T concentration versus time curve (AUC) for 28 days after IMV102 administration
Time frame: From first dose of IMV102 to 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
Time frame: From first dose of IMV102 to 90 days after IMV102 administration
Efficacy of IMV102 injection
Overall response rate after IMV102 infusion
Time frame: about 2 years
Efficacy of IMV102 injection
Overall survival after IMV102 infusion
Time frame: about 2 years
Efficacy of IMV102 injection
Progress-free survival after IMV102 infusion
Time frame: about 2 years
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