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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants (NCT06566092) is a Phase 1 interventional studying Soft Tissue Sarcoma and Primary Central Nervous System Carcinoma, sponsored by Iovance Biotherapeutics, INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Soft Tissue Sarcoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participant is ≥ 8 kg and ≤ 21 years of age at the time of willing to sign a consent form and assent. 2. diagnosed by tissue sample (biopsy-confirmed) recurrent or refractory solid tumor (Rhabdomyosarcoma, Ewing sarcoma, primary CNS malignancies, melanoma) after standard therapy which has failed all available curative therapy. 3. Acceptable performance status and an estimated life expectancy of \> 6 months. 4. At least one resectable lesion (solitary or aggregate lesions) for TIL generation. 5. Following tumor resection for TIL generation, the participant will have at least one remaining measurable lesion for response assessment. 6. Preplanned surgical procedure(s) will take place at least 14 days (for major operative procedures) prior to the tumor resection. 7. All prior anticancer treatment-related AEs should be recovered, exceptions are peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine dysfunction. 8. 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. 9. Signed willing to sign a consent form and assent when applicable. 10. Written authorization for use and disclosure of protected health information. 11. Ability to adhere to the study visit schedule and other protocol requirements. 12. Acceptable hematologic parameters. 13. your organs (liver, kidneys, etc.) are working well enough based on blood tests. 14. Modified Ross criteria class 1 and an LVFS \> 25% or an LVEF ≥ 50%. 15. Adequate pulmonary function. 16. Participant and/or the legal guardian who provided consent is willing for the participant to receive optimal supportive care. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and assent. 2. 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. 3. Acceptable performance status and an estimated life expectancy of \> 6 months. 4. At least one resectable lesion (solitary or aggregate lesions) for TIL generation. 5. Following tumor resection for TIL generation, the participant will have at least one remaining measurable lesion for response assessment. 6. Preplanned surgical procedure(s) will take place at least 14 days (for major operative procedures) prior to the tumor resection. 7. All prior anticancer treatment-related AEs should be recovered, exceptions are peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine dysfunction. 8. 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. 9. Signed informed consent and assent when applicable. 10. Written authorization for use and disclosure of protected health information. 11. Ability to adhere to the study visit schedule and other protocol requirements. 12. Acceptable hematologic parameters. 13. Adequate organ function. 14. Modified Ross criteria class 1 and an LVFS \> 25% or an LVEF ≥ 50%. 15. Adequate pulmonary function. 16. Participant and/or the legal guardian who provided consent is willing for the participant to receive optimal supportive care. 17. 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. Exclusion Criteria: 1. Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or carcinomatous meningitis. 2. Participant has an active or uncontrolled intercurrent illness(es) that would pose increased risks for study participation. 3. Participants are not eligible if they experience uncontrolled seizures. 4. Participants with history of intracranial hemorrhage/spinal cord hemorrhage. 5. Participant has active uveitis that requires active treatment. 6. Participant has significant psychiatric disease or substance abuse in the investigator's opinion that would prevent adequate informed consent. 7. Participant has any form of primary or acquired immunodeficiency. 8. History of clinically significant chronic obstructive pulmonary disease, asthma, interstitial lung disease, or other chronic lung disease. 9. History of hypersensitivity reaction to any components of the study intervention. 10. Any other condition that in the investigator's judgment would significantly increase the risks of participation. 11. Any complication or delayed healing from an excisional procedure that in the investigator's opinion would increase the risks of participation. 12. Another primary malignancy within the previous 3 years. 13. History of allogeneic cell or organ transplant. 14. Requiring systemic steroid therapy higher than the physiologic replacement dose. 15. Received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD. 16. Any active viral, bacterial, or fungal infection requiring ongoing systemic treatment.

Treatments Being Tested

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.

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Children's Hospital of Colorado
Aurora, Colorado, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06566092), the sponsor (Iovance Biotherapeutics, INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06566092 clinical trial studying?

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 Ye… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06566092?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06566092?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06566092. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06566092. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.