RecruitingPhase 1NCT06566092

Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants

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

Sponsor

Iovance Biotherapeutics, Inc.

Enrollment

40 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma Melanoma Ewing Sarcoma Rhabdomyosarcoma Primary Central Nervous System Carcinoma

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.

Eligibility

Min Age: 6 MonthsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tumor-infiltrating lymphocytes (TILs) — immune cells taken from the patient's own tumor, grown in the lab, and then infused back — in children and young adults up to age 21 with relapsed or refractory solid tumors (rhabdomyosarcoma, Ewing sarcoma, brain cancers, or melanoma) that have not responded to all available curative options. **You may be eligible if...** - You are between 8 kg in weight and 21 years old - You have a confirmed relapsed or treatment-resistant solid tumor (rhabdomyosarcoma, Ewing sarcoma, a primary brain tumor, or melanoma) - You have at least one tumor that can be surgically removed to generate TILs, and at least one other tumor remaining for treatment response measurement - Your general health and organ function are adequate **You may NOT be eligible if...** - Your tumor cannot be surgically accessed for TIL generation - Your cancer has no measurable remaining disease after surgery - You have significant ongoing side effects from previous treatment - You are pregnant - Your organ function is too impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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