Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
NCT06566092 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-06
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.
Conditions
- Soft Tissue Sarcoma
- Primary Central Nervous System Carcinoma
- Melanoma
- Rhabdomyosarcoma
- Ewing Sarcoma
Interventions
- BIOLOGICAL
-
LN-145/LN-144
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Sponsors & Collaborators
-
Iovance Biotherapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Iovance Biotherapeutics Study Team · Iovance Biotherapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-28
- Primary Completion
- 2026-07-31
- Completion
- 2028-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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