Testing IMV102 in people whose multiple myeloma has returned or stopped responding
Tests the safety and effect of IMV102 in adults with relapsed multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study of IMV102 in Patients With Relapsed/Refractory Multiple Myeloma
Key facts
- Where
- Beijing, Chongqing, Shanghai, and Zhengzhou, ChinaSee the 4 sites
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07493135, who can take part
Where in China
- Beijing Gobroad Boren HospitalBeijing, ChinaTaking people
- The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
- Renji Hospital Shanghai Jiao Tong University School of MedicineShanghai, ChinaNot yet recruiting
- Zhengzhou Yihe HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Immunofoco Biotechnology Co., Ltd
- Trial code
- NCT07493135
- Record updated
- 3 September 2026
- Original description
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.Read full original descriptionShow less
A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed/Refractory Multiple Myeloma
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.
Inclusion: 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.
Exclusion: Other Malignancies: Subjects with a prior or concurrent other malignancy; Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment; 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; 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; 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; Pregnancy/Lactation: Women who are pregnant or breastfeeding; Compliance: Subjects whom the investigator assesses as unable or unwilling to comply with the requirements of the study protocol.