Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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