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

March 31, 2026 updated by: Iovance Biotherapeutics, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital of Colorado
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melanoma
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.
Experimental: Rhabdomyosarcoma (RMS)
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.
Experimental: Ewing Sarcoma (EWS)
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.
Experimental: Primary Central Nervous System Tumor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of Treatment-Emergent Adverse Events
Time Frame: Up to 24 months
To evaluate the safety and tolerability of the TIL regimen that occurs from the start of TIL infusion and up to 30 days after TIL infusion per CTCAE.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Up to 24 months
To evaluate the proportion of participants who have confirmed complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO.
Up to 24 months
Duration of Response
Time Frame: Up to 24 months
To measure the time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO.
Up to 24 months
Disease Control Rate
Time Frame: Up to 24 months
To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RECIST v1.1 or RAPNO.
Up to 24 months
Progression-Free Survival
Time Frame: Up to 24 months
To evaluate the time from the date of the TIL infusion until disease progression per RECIST v1.1 or RAPNO.
Up to 24 months
Overall Survival
Time Frame: Up to 24 months
To measure the time from the date of TIL infusion to death due to any cause.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iovance Biotherapeutics, Inc.

Investigators

  • Study Director: Iovance Biotherapeutics Study Team, Iovance Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-PED-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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