Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT06626256
Eligibility Criteria:
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative.
* Assent, when appropriate, will be obtained per institutional guidelines
* Agree to research biopsies while on-study
* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening, while the request for a translated full consent is processed
* Age: ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
* Anticipated life expectancy of \> 6 months at the time of enrollment
* Participants with pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CC), renal cell carcinoma (RCC), cervical cancer (CC) and melanoma, meeting the following criteria will be eligible:
* Cytologically or histologically confirmed locally advanced, unresectable, or metastatic PDAC, CRC, RCC, CC, melanoma
* Patients must have received at least 1 line of standard therapy prior to receiving STIL101 for injection. Note: Patients may be enrolled prior to starting treatment to harvest tumor and blood samples for tumor infiltrating lymphocyte (TIL) generation
* For pancreatic cancer patients:
* Patients on first line treatment will need to receive at least 4 months of standard chemotherapy before receiving STIL101 for injection
* In the second line setting, these patients may opt to receive STIL101 for injection at any time
* For melanoma cancer patients: Patients need to have received prior PD1 therapy and BRAF inhibitor treatment in patients with a V600E mutation
* For RCC, CRC, CC patients: Patients need to have failed at least 1 line of prior therapy
* Measurable disease by RECIST 1.1
* At least one lesion (or aggregate of lesions resected) that can be safety biopsied (excisional) and yield a volume (target of \> 1cm\^3) to generate STIL101 for injection (principal investigator \[PI\] discretion)
* Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
* NOTE: Growth factor is not permitted within 14 days of screening ANC assessment
* Platelets ≥ 100,000/mm\^3
* NOTE: Platelet transfusions are not permitted within 14 days of screening platelet assessment
* Hemoglobin ≥ 8 g/dL
* NOTE: Red blood cell transfusions are not permitted within 14 days of screening platelet assessment
* Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless participant has Gilbert's disease which allows total bilirubin ≤ 3 x ULN)
* Aspartate aminotransferase (AST) ≤ 3 x ULN; ≤ 5.0 x ULN if hepatic metastases are present
* Alanine transaminase (ALT) ≤ 3 x ULN; ≤ 5.0 x ULN if hepatic metastases are present
* Creatinine clearance (CRCl) of ≥ 40 mL/min per 24-hour urine test or the Cockcroft-Gault formula
* Oxygen (O2) saturation \> 92% on room air not requiring oxygen supplementation
* Note: To be performed within 28 days prior to start of protocol therapy
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Note: To be performed within 8 weeks prior to start of protocol therapy
* If not receiving anticoagulants: International normalized ratio (INR) or prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
* Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative), and syphilis (RPR)
* If seropositive for HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetected
* QuantiFERON-TB Gold or equivalent
* Results do not impact patient eligibility; however, the test must be initiated prior to enrollment
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion Criteria:
* Prior organ transplant
* Concomitant herbal medications with exception to cannabidiol (CBD), which is allowed
* Continuous systemic steroid therapy (i.e., \> 10 mg/day of prednisone or other steroid equivalent dose) or other immunosuppressive therapies. Physical replacement doses (i.e., adrenocortical insufficiency), inhaled or topical steroids at ≤ 10 mg/day of prednisone or another steroid equivalent dose are permissible in the absence of active auto-immune disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents, including history of hypersensitivity to any drugs of the aminoglycoside group
* Prior or current known uveitis within 6 months of informed consent
* Active viral, bacterial, or fungal infection requiring treatment. Patients must be seronegative for the human immunodeficiency virus (HIV) and syphilis (RPR). Patients with hepatitis infections are allowed with undetected viral load
* Primary immunodeficiency (such as severe combined immunodeficiency \[SCID\] or acquired immunodeficiency syndrome \[AIDS\])
* End-stage renal disorder requiring hemodialysis
* Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification
* Known clinically significant pulmonary conditions within 6 months of informed consent
* Prior or concurrent malignancy. Prior malignancies with a low probability of recurrence requiring treatment such as the following are allowed: carcinoma in situ of the cervix, nonmelanoma skin cancer and low grade (Gleason score ≤ 6=Gleason group 1) localized prostate cancer. Prior malignancies not listed require PI approval
* Females only: Pregnant or breastfeeding
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06626256
Study Brief:
Protocol Section:
NCT06626256