A Study of DeTIL-0255 in Adults With Advanced Malignancies

This is an interventional treatment trial for Platinum-resistant Ovarian Cancer focused on measuring NX-DeTIL-0255, Adoptive Cell Therapy, Tumor Infiltrating Lymphocyte, ACT, TIL, DeTIL Read More

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