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

NCT06566092 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IOV-PED-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Tumor Infiltrating Lymphocytes; TIL; Pediatric; Soft Tissue Sarcoma; Primary Nervous System Carcinoma; PCNS; Rhabdomyosarcoma; RMS; Ewing Sarcoma; EWS

Outcome Measures

Primary Outcomes (1)

• Incidence rate of Treatment-Emergent Adverse Events

  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 Outcomes (5)

• Objective Response Rate

  Up to 24 months

• Duration of Response

  Up to 24 months

• Disease Control Rate

  Up to 24 months

• Progression-Free Survival

  Up to 24 months

• Overall Survival

  Up to 24 months

Study Arms (4)

Rhabdomyosarcoma (RMS)

EXPERIMENTAL

Biological: LN-145/LN-144

Ewing Sarcoma (EWS)

EXPERIMENTAL

Biological: LN-145/LN-144

Primary Central Nervous System Tumor

EXPERIMENTAL

Biological: LN-145/LN-144

Melanoma

EXPERIMENTAL

Biological: LN-145/LN-144

Interventions

LN-145/LN-144 BIOLOGICAL

A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.

Ewing Sarcoma (EWS); Melanoma; Primary Central Nervous System Tumor; Rhabdomyosarcoma (RMS)

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or carcinomatous meningitis.
• Participant has an active or uncontrolled intercurrent illness(es) that would pose increased risks for study participation.
• Participants are not eligible if they experience uncontrolled seizures.
• Participants with history of intracranial hemorrhage/spinal cord hemorrhage.
• Participant has active uveitis that requires active treatment.
• Participant has significant psychiatric disease or substance abuse in the investigator's opinion that would prevent adequate informed consent.
• Participant has any form of primary or acquired immunodeficiency.
• History of clinically significant chronic obstructive pulmonary disease, asthma, interstitial lung disease, or other chronic lung disease.
• History of hypersensitivity reaction to any components of the study intervention.
• Any other condition that in the investigator's judgment would significantly increase the risks of participation.
• Any complication or delayed healing from an excisional procedure that in the investigator's opinion would increase the risks of participation.
• Another primary malignancy within the previous 3 years.
• History of allogeneic cell or organ transplant.
• Requiring systemic steroid therapy higher than the physiologic replacement dose.
• Received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.: lead

Study Sites (5)

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14203, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma; Melanoma; Rhabdomyosarcoma; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Myosarcoma; Neoplasms, Muscle Tissue; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Study Officials

• Iovance Biotherapeutics Study Team

  Iovance Biotherapeutics

  STUDY DIRECTOR

Central Study Contacts

Iovance Biotherapeutics Study Team

CONTACT

1-844-845-4682; Clinical.Inquiries@iovance.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned one of three arms depending on their tumor type.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 22, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

US (5)