Actively Recruiting
A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IMV102 injection in patients with relapsed or refractory multiple myeloma who have undergone at least three prior therapies. This early-phase clinical study aims to assess the safety and effectiveness of IMV102. The investigation includes dose escalation and expansion phases and is conducted at a single center to better understand how this treatment may affect patients with this condition. Eligible participants will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after the infusion to analyze how the body processes the drug and to check for immune responses and safety. Tumor responses will be assessed using established criteria at several time points, including baseline, Day 28 after infusion, Month 2, Month 3, and then every three months up to 24 months. Participants will be followed for up to 24 months or until disease progression, new therapy initiation, death, or withdrawal from the study. During this time, researchers will monitor safety, drug levels in the body, immune effects, and treatment efficacy. Assessments include clinical evaluations, laboratory tests, and imaging as needed. This close monitoring helps to understand the treatment's impact and safety profile over time.
CONDITIONS
Brief Title
A Study of IMV102 in Patients With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Diagnosed with relapsed or refractory multiple myeloma by IMWG criteria
- Have received at least 3 prior lines of therapy including proteasome inhibitor and immunomodulatory agent
- Agree to use effective contraception from consent until 12 months after last dose
- Provide voluntary written informed consent
- Willing and able to comply with study treatment, tests, and follow-up
You will not qualify if you...
- Currently pregnant or breastfeeding
- Have had any other prior or concurrent malignancy
- Positive for HIV antibody, active hepatitis B or C infection, positive syphilis antibody, or active cytomegalovirus infection
- Presence of uncontrolled infection
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- History of severe allergies including anaphylactic shock or allergy to IMV102 or tocilizumab
- Severe mental disorders
- History of solid organ transplantation
- Unable or unwilling to comply with study protocol
- Any other severe or uncontrolled medical condition making participation unsuitable
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months post-infusion
Participants receive an infusion of IMV102 injection as treatment for relapsed/refractory multiple myeloma.
Follow-up visits up to 24 months post-infusion to evaluate safety and efficacy
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
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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