This is a first-in-human Phase 1 multicenter, open-label oncology study designed to evaluate the safety and efficacy of NX-DeTIL-0255-201 in patients with advanced malignancies.
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Inclusion Criteria: * One of the following malignancies: Recurrent or persistent platinum-resistant EOC, recurrent, metastatic or persistent carcinoma of the cervix with progression after treatment with taxane-containing regimen, or advance or recurrent endometrial cancer with disease progression after or during second line or greater therapy * Disease that is metastatic and measurable by RECIST v1.1 criteria * A resectable lesion for TIL generation * At least 2 prior lines of therapy * ≥ 18 years and ≤ 70 years of age * Life expectancy of at least 4 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ and bone marrow function, in the absence of growth factors * Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol * A signed consent form indicating that the subjects understands the purpose and procedures required for the study Exclusion Criteria: * Known untreated brain metastases * Uncontrolled intercurrent illness * History of known seizure disorder * Unable to comply with study requirements * Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy * Pregnant, breastfeeding, or planning to become pregnant while enrolled on this study or within 6 months after DeTIL infusion * Live vaccine within 28 days of first dose of NMA chemotherapy or planned live vaccination within 6 months following DeTIL infusion * Active known second malignancy with the exception of any of the following: Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or adequately treated follicular or papillary thyroid cancer; or any other cancer from which the patient has been disease-free for ≥ 2 years * Systemic anti-cancer therapy, including investigational agents, or radiotherapy within 4 weeks of tumor resection * Major surgery within 4 weeks before tumor resection, or will not have fully recovered from surgery, or has surgery planned within 8 weeks after infusion * Use of systemic corticosteroids within 15 days (or other immunosuppressive drugs within 30 days) prior to tumor resection * Use of biotin or other supplements containing higher that the daily adequate intake of biotin * Clinically significant, uncontrolled cardiac, class III or IV heart failure, thromboembolic events, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug * History or current evidence of anything that might confound the results of the study