New immune cell therapy trial for advanced cancers withdrawn before starting
NCT ID NCT06626256
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial aimed to test the safety of a new treatment called STIL101 for people with advanced pancreatic, colorectal, kidney, cervical cancer, or melanoma that has spread or cannot be removed. STIL101 is made from a patient's own immune cells taken from their tumor, grown in a lab, and then given back to help fight the cancer. The study was withdrawn before enrolling any participants, so no results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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