Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Part… (NCT06566092) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
United States40 participantsStarted 2024-03-28
Plain-language summary
This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist.
Study details include:
* The study will last up to 2 years after the TIL infusion (Day 0) for each person.
* The treatment will last up to 10 days for each person.
* Study visits will be every 2 weeks until Day 42, every 6 weeks until Month 6, and every 3 months until Year 2.
Who can participate
Age range
6 Months – 21 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
. Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and assent.
. Histologically or cytologically confirmed recurrent or refractory solid tumor (Rhabdomyosarcoma, Ewing sarcoma, primary CNS malignancies, melanoma) after standard therapy which has failed all available curative therapy.
. Acceptable performance status and an estimated life expectancy of \> 6 months.
. At least one resectable lesion (solitary or aggregate lesions) for TIL generation.
. Following tumor resection for TIL generation, the participant will have at least one remaining measurable lesion for response assessment.
. Preplanned surgical procedure(s) will take place at least 14 days (for major operative procedures) prior to the tumor resection.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Incidence rate of Treatment-Emergent Adverse Events
. All prior anticancer treatment-related AEs should be recovered, exceptions are peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine dysfunction.
. Agreement to abide by the protocol indicated contraception use, including refraining from donating sperm or eggs (ova, oocytes), as appropriate for the age and sexual activity of pediatric, adolescent, and young adult participants and as required by local regulations.
Exclusion criteria
. Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or carcinomatous meningitis.
. Participant has an active or uncontrolled intercurrent illness(es) that would pose increased risks for study participation.
. Participants are not eligible if they experience uncontrolled seizures.
. Participants with history of intracranial hemorrhage/spinal cord hemorrhage.
. Participant has active uveitis that requires active treatment.
. Participant has significant psychiatric disease or substance abuse in the investigator's opinion that would prevent adequate informed consent.
. Participant has any form of primary or acquired immunodeficiency.
. History of clinically significant chronic obstructive pulmonary disease, asthma, interstitial lung disease, or other chronic lung disease.