Using patients' own immune cells to fight certain cancers in young people

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 testing whether using young people's own immune cells to fight their hard-to-treat cancers can help them feel better and improve their health.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 6 Months to 21 Years
• Sex: All
• Sponsor: Iovance Biotherapeutics, Inc. (Industry-sponsored)
• Locations: 3 sites (Saint Petersburg, Florida and 2 other locations)
• Trial ID: NCT06566092 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of autologous tumor-infiltrating lymphocytes (TIL) in treating pediatric, adolescent, and young adult patients with recurrent or refractory solid tumors. Participants will undergo a procedure to harvest their immune cells, which will then be infused back into their bodies after being modified to better target cancer cells. The study will monitor participants for up to two years post-infusion to assess the treatment's impact on tumor response and overall health.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 8 kg to 21 years with specific types of solid tumors that have not responded to standard treatments.

Not a fit: Patients with tumors that are not resectable or those who have not failed prior standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for young patients with hard-to-treat cancers.

How similar studies have performed: Other studies using TIL therapy have shown promising results, indicating potential for success in this approach.

Eligibility 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.

Where this trial is running

Saint Petersburg, Florida and 2 other locations

• Johns Hopkins All Children's Hospital — Saint Petersburg, Florida, United States (Recruiting)
• Rutgers Cancer Institute — New Brunswick, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Iovance Biotherapeutics Study Team

Conditions Soft Tissue Sarcoma; Primary Central Nervous System Carcinoma; Melanoma; Rhabdomyosarcoma; Ewing Sarcoma; Tumor Infiltrating Lymphocytes; TIL; Pediatric