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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma [Срок оценки: 24 months post IMV102 infusion]

Вторичные конечные точки (7)

• Assessment of pharmacokinetic (about Cmax) [Срок оценки: 24 months post IMV102 infusion]
• Assessment of pharmacokinetic (about Tmax) [Срок оценки: 24 months post IMV102 infusion]
• Assessment of pharmacokinetic (about AUC0-28d) [Срок оценки: From first dose of IMV102 to 28 days after IMV102 administration]
• Assessment of pharmacokinetic (about AUC0-90d) [Срок оценки: From first dose of IMV102 to 90 days after IMV102 administration]
• Efficacy of IMV102 injection [Срок оценки: about 2 years]
• Efficacy of IMV102 injection [Срок оценки: about 2 years]
• Efficacy of IMV102 injection [Срок оценки: about 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Beijing GoBroad Boren Hospital — Пекин
• The second affiliated hospital of Chongqing medical university — Чунцин
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• Zhengzhou Yihe Hospital — Чжэнчжоу

Идентификаторы

NCT: NCT07493135 · IMV102-CT02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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