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

Phase 1

Recruiting

• Conditions: Soft Tissue Sarcoma; Melanoma; Rhabdomyosarcoma; Primary Central Nervous System Carcinoma; Ewing Sarcoma

• Registration Number: NCT06566092
• Lead Sponsor: Iovance Biotherapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Participant is = 8 kg and = 21 years of age at the time of informed consent and<br> assent.<br><br> 2. Histologically or cytologically confirmed recurrent or refractory solid tumor<br> (Rhabdomyosarcoma, Ewing sarcoma, primary CNS malignancies, melanoma) after standard<br> therapy which has failed all available curative therapy.<br><br> 3. Acceptable performance status and an estimated life expectancy of > 6 months.<br><br> 4. At least one resectable lesion (solitary or aggregate lesions) for TIL generation.<br><br> 5. Following tumor resection for TIL generation, the participant will have at least one<br> remaining measurable lesion for response assessment.<br><br> 6. Preplanned surgical procedure(s) will take place at least 14 days (for major<br> operative procedures) prior to the tumor resection.<br><br> 7. All prior anticancer treatment-related AEs should be recovered, exceptions are<br> peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine<br> dysfunction.<br><br> 8. Agreement to abide by the protocol indicated contraception use, including refraining<br> from donating sperm or eggs (ova, oocytes), as appropriate for the age and sexual<br> activity of pediatric, adolescent, and young adult participants and as required by<br> local regulations.<br><br> 9. Signed informed consent and assent when applicable.<br><br> 10. Written authorization for use and disclosure of protected health information.<br><br> 11. Ability to adhere to the study visit schedule and other protocol requirements.<br><br> 12. Acceptable hematologic parameters.<br><br> 13. Adequate organ function.<br><br> 14. Modified Ross criteria class 1 and an LVFS > 25% or an LVEF = 50%.<br><br> 15. Adequate pulmonary function.<br><br> 16. Participant and/or the legal guardian who provided consent is willing for the<br> participant to receive optimal supportive care.<br><br> 17. A legal guardian or primary caregiver must be available to help the study-site<br> personnel ensure follow-up and accompany the participant to the study site on each<br> assessment day according to the SoA.<br><br>Exclusion Criteria:<br><br> 1. Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or<br> carcinomatous meningitis.<br><br> 2. Participant has an active or uncontrolled intercurrent illness(es) that would pose<br> increased risks for study participation.<br><br> 3. Participants are not eligible if they experience uncontrolled seizures.<br><br> 4. Participants with history of intracranial hemorrhage/spinal cord hemorrhage.<br><br> 5. Participant has active uveitis that requires active treatment.<br><br> 6. Participant has significant psychiatric disease or substance abuse in the<br> investigator's opinion that would prevent adequate informed consent.<br><br> 7. Participant has any form of primary or acquired immunodeficiency.<br><br> 8. History of clinically significant chronic obstructive pulmonary disease, asthma,<br> interstitial lung disease, or other chronic lung disease.<br><br> 9. History of hypersensitivity reaction to any components of the study intervention.<br><br> 10. Any other condition that in the investigator's judgment would significantly increase<br> the risks of participation.<br><br> 11. Any complication or delayed healing from an excisional procedure that in the<br> investigator's opinion would increase the risks of participation.<br><br> 12. Another primary malignancy within the previous 3 years.<br><br> 13. History of allogeneic cell or organ transplant.<br><br> 14. Requiring systemic steroid therapy higher than the physiologic replacement dose.<br><br> 15. Received or will receive a live or attenuated vaccination within 28 days prior to<br> the start of the NMA-LD.<br><br> 16. Any active viral, bacterial, or fungal infection requiring ongoing systemic<br> treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of Treatment-Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate;Duration of Response;Disease Control Rate;Progression-Free Survival;Overall Survival