A Phase 1, Multicenter, Open-label, 2-stage, Single-arm Study to Evaluate the Safety and Tolerability of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen and Preliminary Antitumor Activity of TIL in Pediatric, Adolescent, and Young Adult Participants With Relapsed or Refractory Solid Tumors
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.
• 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.
• 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.
• Signed informed consent and assent when applicable.
⁃ Written authorization for use and disclosure of protected health information.
⁃ Ability to adhere to the study visit schedule and other protocol requirements.
⁃ Acceptable hematologic parameters.
⁃ Adequate organ function.
⁃ Modified Ross criteria class 1 and an LVFS \> 25% or an LVEF ≥ 50%.
⁃ Adequate pulmonary function.
⁃ Participant and/or the legal guardian who provided consent is willing for the participant to receive optimal supportive care.
⁃ A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up and accompany the participant to the study site on each assessment day according to the SoA.