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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Months - 21 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06566092
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Iovance Biotherapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Iovance Biotherapeutics Study Team
Principal Investigator Affiliation Iovance Biotherapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Soft Tissue Sarcoma, Primary Central Nervous System Carcinoma, Melanoma, Rhabdomyosarcoma, Ewing Sarcoma
Arms & Interventions

Arms

Experimental: Rhabdomyosarcoma (RMS)

Experimental: Ewing Sarcoma (EWS)

Experimental: Primary Central Nervous System Tumor

Experimental: Melanoma

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rutgers Cancer Institute, New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Stay Informed & Connected