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RECRUITING
NCT07493135
EARLY_PHASE1

A Study of IMV102 in Patients With Relapsed/Refractory Multiple Myeloma

Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed/Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-03-31

Completion Date

2028-04-01

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

IMV102 treatment

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.

Locations (4)

Beijing GoBroad Boren Hospital

Beijing, China

The second affiliated hospital of Chongqing medical university

Chongqing, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Zhengzhou Yihe Hospital

Zhengzhou, China