TIL Therapy in Non-small-cell Lung Cancer (NSCLC) Patients

Korábbi kezelés

• Active central nervous system (CNS) metastases. Patients with stable CNS metastases ≥ 1 month after definitive treatment (eg, surgery and/or radiotherapy) are eligible.
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol, including autoimmune or immunodeficient conditions, significant pulmonary disease, significant cardiac and/or vascular disease per investigator's judgment.
• Prior immune-related adverse events that would preclude re-challenge with an immune checkpoint inhibitor or immunomodulatory agent per investigator's judgment.
• Immunosuppressive treatment that would preclude the patient from any of the study therapies per investigator's judgment.

Más betegség

• Participants with an active second malignancy.
• Severe active infections or uncontrolled infectious conditions requiring treatment.
• Any other conditions/diseases, allergies, dysfunctions, and/or findings, that would contraindicate the use of any of the study interventions or therapies.
• Known hypersensitivity to any of study therapies or drugs used for TIL production.
• Known human immunodeficiency virus (HIV) infection (or tests positive for HIV 1 or 2 at Screening).
• Known hepatitis B or hepatitis C infection.

Egyéb

• Contraindication for any of the planned measures, interventions and/or treatments.
• Pregnant or breastfeeding women, or female subject who are not willing to use an acceptable, highly effective method of contraception until the End-of-Study visit.

• Ability of the patient to understand the purpose of the study, provide signed and dated informed consent prior to performing any protocol-related procedures (including screening evaluations), and be able and willing to comply with the study procedures.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 (cf. Appendix).
• Histologically confirmed NSCLC.
• Disease progression after at least one standard therapy and without any approved curative-intended treatment option.
• Accessible tumor lesion/metastasis for tumor collection.
• Willingness of the patient to undergo a surgical intervention (eg, surgical resection and/or biopsy) to collect one or more tumor lesions/metastases.
• Adequate organ function (pulmonary, cardiovascular, hematological, hepatic, and renal function) per investigator's judgment. Cardiac stress testing is required for all patients with underlying cardiac conditions and patients with age ≥ 50 years.
• Negative serum pregnancy test in women of childbearing potential, in peri-menopausal women and in women with less than 2 years of menopause.