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

NCT07493135 | Recruiting Early Phase 1

• 1 other identifier: IMV102-CT02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma

  Incidence of adverse events and its severity after IMV102 injection treatment

  24 months post IMV102 infusion

Secondary Outcomes (7)

• Assessment of pharmacokinetic (about Cmax)

  24 months post IMV102 infusion

• Assessment of pharmacokinetic (about Tmax)

  24 months post IMV102 infusion

• Assessment of pharmacokinetic (about AUC0-28d)

  From first dose of IMV102 to 28 days after IMV102 administration

• Assessment of pharmacokinetic (about AUC0-90d)

  From first dose of IMV102 to 90 days after IMV102 administration

• Efficacy of IMV102 injection

  about 2 years

Study Arms (1)

IMV102 treatment group

EXPERIMENTAL

Biological: IMV102 treatment

Interventions

IMV102 treatment BIOLOGICAL

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.

IMV102 treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Aged 18 to 80 years (inclusive), of either sex.
• Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• 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).
• 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.
• Informed Consent: Subjects must voluntarily sign and date a written informed consent form (ICF) indicating agreement to participate in this study.
• Compliance: Subjects must be willing and able to comply with the scheduled treatment plan, laboratory tests, follow-up, and other study requirements.

You may not qualify if:

• Pregnancy/Lactation: Women who are pregnant or breastfeeding.
• Other Malignancies: Subjects with a prior or concurrent other malignancy.
• 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).
• Presence of clinically active uncontrolled infection based on assessment done by treating physicians.
• Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment.
• 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.
• Psychiatric Disorders: Subjects with severe mental disorders.
• Transplant History: History of solid organ transplantation.
• Compliance: Subjects whom the investigator assesses as unable or unwilling to comply with the requirements of the study protocol.
• 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.

Sponsors & Collaborators

• Suzhou Immunofoco Biotechnology Co., Ltd: lead

Study Sites (4)

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

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Juan Du, MD

CONTACT

15800706091; Juan_du@live.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)