A Clinical Study on TIL for the Treatment of Advanced Solid Tumors (NCT05087745) | Clinical Trial Compass
RecruitingEarly Phase 1
A Clinical Study on TIL for the Treatment of Advanced Solid Tumors
China50 participantsStarted 2021-12-10
Plain-language summary
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18 years to 75 years;
. Histologically diagnosed as primary/relapsed/metastasized solid tumors ;
. Expected life-span more than 3 months;
. Karnofsky≥60% or ECOG score 0-2;
. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
. At least 1 evaluable tumor lesion;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an early Phase 1 trial using tumor-infiltrating lymphocytes, what do we actually know so far about how safe this treatment is, and what types of side effects have been reported in patients with advanced solid tumors like mine?
2TIL therapy typically involves removing a piece of my tumor, growing my own immune cells in a lab, and then putting them back into my body — is my specific tumor type and overall health situation even compatible with that process, and are there logistical hurdles I should be aware of upfront?
3Because this is such an early-phase study, the primary goal is largely to understand safety and get early signals on response — given that, would it make more sense for me to try a standard treatment first before considering an experimental option like this?
4The trial is measuring how long responses last and how long patients go without their disease progressing — has my doctor seen any early signals from similar TIL studies that would help me understand whether this approach has shown any promise for my particular type of advanced solid tumor?
5What would happen to my care and treatment options if I enrolled in this trial and my disease progressed — would I still be able to access other therapies, or could participation in this study limit what I could try next?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Hematology and Chemistry（within 7 days prior to enrollment）:
Exclusion criteria
. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
. Severe physical or mental diseases;
. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;