A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer

Официальное название

A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer

Обзор

The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.

Подробное описание

A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART™ designed IL-2 cytokine in platinum-resistant ovarian cancer.

Вмешательства

• Биопрепарат OPB-101
  An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine

Первичные конечные точки

• Safety [Срок оценки: 28 days]
• Safety [Срок оценки: 2 years]
• Safety [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Age ≥ 18 years of age at the time of signing the informed consent form.
• Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
• Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
• Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
• Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
• Measurable disease.
• Consent to provide archived tumor tissue sample.
• ECOG performance status of 0 or 1.
• Adequate organ function.
• Alkaline phosphatase ≤ 2.5 x ULN
• ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) > 92% on room air.
• LVEF ≥ 50%
• Life expectancy of ≥ 3 months
• Adequate venous access.
• Negative screen for infectious disease markers.
• Negative serum pregnancy test.
• Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.

Note: Other protocol defined inclusion criteria could apply

Критерии исключения

• Women of child-bearing potential who are pregnant or breastfeeding.
• Uncontrolled bacterial, fungal, or viral infections.
• Active infection requiring systemic therapy.
• Bleeding or thrombotic disorders or at risk for severe hemorrhage.
• Any form of primary immunodeficiency.
• Had an allogenic tissue/solid organ transplant.
• Active autoimmune disease.
• Concurrent treatment with systemic high dose corticosteroids.
• Unresolved acute effects of any prior therapy.
• Active invasive cancer other than the cancer under study.
• Significant lung disease.
• Clinically significant pericardial effusion.
• Prior radiotherapy within 2 weeks of start of study intervention.
• No major surgery within 28 days prior to enrollment.
• Received investigational agents or tumor vaccines.
• Received chemotherapy within the previous 3 weeks.
• History of grade ≥ 3 ascites.
• Active CNS involvement.
• Received a live vaccine within 30 days prior to study treatment.
• Received prior CAR T cell therapy.
• Received prior mesothelin targeted therapy.
• Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply

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

США · 4 центра

• Karmanos Cancer Institute — Detroit
• University of Minnesota — Minneapolis
• Roswell Park — Buffalo
• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT07030907 · OPB-101-OV-101A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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