IMV102 treatment for relapsed or refractory multiple myeloma

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

This trial will try a single infusion of IMV102 in adults with relapsed or refractory multiple myeloma who have had at least three prior therapies to see if it is safe and helps control the cancer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd (Industry-sponsored)
• Drugs / interventions: tocilizumab
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT07493135 on ClinicalTrials.gov

What this trial studies

This investigator-initiated, early-phase study uses a dose-escalation followed by a dose-expansion design to identify a safe and potentially active dose of IMV102 in relapsed/refractory multiple myeloma. Eligible participants receive an infusion of IMV102 with serial blood and urine sampling for pharmacokinetics, pharmacodynamics, immunogenicity, and safety monitoring. Tumor response will be measured using the 2016 IMWG uniform response criteria at baseline, Day 28, Month 2, Month 3, and then every three months up to 24 months or until progression or withdrawal. The trial collects safety and preliminary efficacy data to inform whether further development is warranted.

Who should consider this trial

Good fit: Adults aged 18–80 with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, with ECOG performance status 0–2 and agreement to required contraception.

Not a fit: Patients with fewer than three prior lines of therapy, ECOG >2, or significant uncontrolled organ dysfunction are unlikely to be eligible or to receive benefit from this investigational infusion.

Why it matters

Potential benefit: If successful, IMV102 could offer a new treatment option that helps control disease or extend remission for patients with heavily pretreated multiple myeloma.

How similar studies have performed: Similar early-phase immunotherapies and novel agents in heavily pretreated myeloma have shown promising signals in some programs, but IMV102 itself is a novel agent and remains unproven.

Eligibility criteria

Inclusion Criteria:

1. Age: Aged 18 to 80 years (inclusive), of either sex.
2. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
3. Diagnosed with relapsed/refractory multiple myeloma according to the IMWG criteria, who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent-based regimen).
4. Reproductive Status: Subjects of childbearing potential and their partners must agree to use medically accepted highly effective contraceptive methods (e.g., intrauterine device, condom) from the time of signing the informed consent form until 12 months after the last dose. They must not donate germ cells, including sperm or oocytes, during this period.
5. Informed Consent: Subjects must voluntarily sign and date a written informed consent form (ICF) indicating agreement to participate in this study.
6. Compliance: Subjects must be willing and able to comply with the scheduled treatment plan, laboratory tests, follow-up, and other study requirements.

Exclusion Criteria:

1. Pregnancy/Lactation: Women who are pregnant or breastfeeding.
2. Other Malignancies: Subjects with a prior or concurrent other malignancy.
3. Infectious Diseases: Positive for human immunodeficiency virus (HIV) antibody; active hepatitis B virus infection (HBV-DNA \> 10³ IU/mL); acute or chronic active hepatitis C (HCV antibody positive); positive syphilis antibody; cytomegalovirus (CMV) infection (IgM positive or DNA positive).
4. Presence of clinically active uncontrolled infection based on assessment done by treating physicians.
5. Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment.
6. Allergies: History of other severe allergies such as anaphylactic shock; known severe allergic reaction to IMV102 or any of its components; known severe allergic reaction to tocilizumab.
7. Psychiatric Disorders: Subjects with severe mental disorders.
8. Transplant History: History of solid organ transplantation.
9. Compliance: Subjects whom the investigator assesses as unable or unwilling to comply with the requirements of the study protocol.
10. Other Conditions: Subjects with any other concurrent severe and/or uncontrolled medical conditions that, in the judgment of the investigator, make them unsuitable for participation in this study.

Where this trial is running

Beijing and 3 other locations

• Beijing GoBroad Boren Hospital — Beijing, China (Recruiting)
• The second affiliated hospital of Chongqing medical university — Chongqing, China (Not_yet_recruiting)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Zhengzhou Yihe Hospital — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Juan Du, MD

Conditions Relapsed/Refractory Multiple Myeloma