A Phase I Trial of Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes and ANV419 in Patients With Advanced Melanoma. The BaseTIL-03M Trial
In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes (TIL) adoptive cell therapy (ACT) incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma
⁃ Patients who meet all the following criteria will be eligible to participate in the study:
• Must provide written informed consent for the study.
• Must be able to comply with the study protocol as judged by the investigator.
• Are ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Have pathologically confirmed stage III (unresectable) or stage IV (metastatic) cutaneous melanoma, as per the American Joint Committee on Cancer staging system, 8th edition, and have experienced disease progression and exhausted all approved treatment option with curative intent.
• Have received at least one prior systemic treatment line of PD-(L)1 inhibitor and BRAF/MEK inhibition in case of BRAFV600 mutated melanoma. Adjuvant systemic treatment terminated ≥12 months prior to diagnosis of metastatic disease is not counted as a treatment line.
• Accessible tumor lesion(s) for TIL collection and willingness of the patient to undergo biopsy/resection of tumor lesion(s).
• Measurable disease as per RECIST v1.1 (following biopsy/resection of tumor lesion(s) for TIL collection).
• Adequate organ function (pulmonary, cardiovascular, hematological, hepatic, and renal function) per investigator's judgment. Cardiac stress testing is mandatory for all patients with underlying cardiac conditions and patients with age ≥50 years. 10. Female patients of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative serum pregnancy test within 72 hours prior to start of preparative chemotherapy (day -7 in the study protocol).
• Female patients who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the entire study period and for 6 months after the last dose of study drug. They must also agree not to donate eggs (ova, oocytes) during the same timeframe.
• Male patients with partners of childbearing potential must agree to use highly effective methods of contraception and barrier contraception (condom) during the entire study period and for 6 months after the last dose of study drug. They must also agree not to donate sperm during the same timeframe.