A Study of DeTIL-0255 in Adults With Advanced Malignancies
NCT ID: NCT05107739
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2021-12-22
2023-05-09
Brief Summary
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Detailed Description
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Recurrent or persistent platinum-resistant epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube carcinoma Recurrent, metastatic, or persistent cervical carcinoma Advanced or recurrent endometrial cancer
Cohort expansion will include patients with advanced malignancies who have received at least two prior systemic therapies in the same indications.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety Run In
Patients with gynecological malignancies
Drug Product De-TIL-0255
Autologous tumor-infiltrating lymphocytes
EOC
Recurrent or persistent platinum-resistant epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube carcinoma
Drug Product De-TIL-0255
Autologous tumor-infiltrating lymphocytes
Cervical
Recurrent, metastatic, or persistent cervical carcinoma
Drug Product De-TIL-0255
Autologous tumor-infiltrating lymphocytes
Endometrial
Advanced or recurrent endometrial cancer
Drug Product De-TIL-0255
Autologous tumor-infiltrating lymphocytes
Interventions
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Drug Product De-TIL-0255
Autologous tumor-infiltrating lymphocytes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Nurix Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paula O'Connor
Role: STUDY_DIRECTOR
Nurix Therapeutics, Inc.
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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NX-DeTIL-0255-201
Identifier Type: -
Identifier Source: org_study_id
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