Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
NCT07493135

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

Led by Suzhou Immunofoco Biotechnology Co., Ltd · Updated on 2026-03-30

30

Participants Needed

4

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 80 years (inclusive), of any gender
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Diagnosed with relapsed/refractory multiple myeloma by IMWG criteria
  • Received at least 3 prior lines of therapy including proteasome inhibitor and immunomodulatory agent
  • Agree to use highly effective contraception from consent until 12 months after last dose if of childbearing potential
  • Willing and able to comply with treatment plan, lab tests, follow-up, and study requirements
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Prior or concurrent other malignancies
  • Positive for HIV antibody
  • Active hepatitis B infection with HBV-DNA > 10³ IU/mL
  • Acute or chronic active hepatitis C (HCV antibody positive)
  • Positive syphilis antibody
  • Cytomegalovirus infection (IgM or DNA positive)
  • Clinically active uncontrolled infection
  • Uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment
  • History of severe allergies including anaphylactic shock or severe reaction to IMV102 or tocilizumab
  • Severe mental disorders
  • History of solid organ transplantation
  • Unable or unwilling to comply with study requirements
  • Other severe or uncontrolled medical conditions making participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Beijing GoBroad Boren Hospital

Beijing, China

Actively Recruiting

2

The second affiliated hospital of Chongqing medical university

Chongqing, China

Not Yet Recruiting

3

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Not Yet Recruiting

4

Zhengzhou Yihe Hospital

Zhengzhou, China

Not Yet Recruiting

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Research Team

J

Juan Du, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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