A Study of IMV102 in Patients With Relapsed/Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMV102 treatment.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Multiple Myeloma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed/Refractory Multiple Myeloma
Overview
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.
Interventions
- Biological IMV102 treatment
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.
Primary outcome measures
- To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma [Time frame: 24 months post IMV102 infusion]
Secondary outcome measures (7)
- Assessment of pharmacokinetic (about Cmax) [Time frame: 24 months post IMV102 infusion]
- Assessment of pharmacokinetic (about Tmax) [Time frame: 24 months post IMV102 infusion]
- Assessment of pharmacokinetic (about AUC0-28d) [Time frame: From first dose of IMV102 to 28 days after IMV102 administration]
- Assessment of pharmacokinetic (about AUC0-90d) [Time frame: From first dose of IMV102 to 90 days after IMV102 administration]
- Efficacy of IMV102 injection [Time frame: about 2 years]
- Efficacy of IMV102 injection [Time frame: about 2 years]
- Efficacy of IMV102 injection [Time frame: about 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Beijing GoBroad Boren Hospital — Beijing
- The second affiliated hospital of Chongqing medical university — Chongqing
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
- Zhengzhou Yihe Hospital — Zhengzhou
Identifiers
NCT: NCT07493135 · IMV102-CT02