TIL Therapy in Non-small-cell Lung Cancer (NSCLC) Patients
A Phase II Trial of Adoptive Cell Therapy With Tumor-infiltrating Lymphocytes in Patients With Non-Small Cell Lung Cancer
University Hospital, Basel, Switzerland
30 participants
Jan 22, 2025
INTERVENTIONAL
Summary
Aim of the study is to investigate the efficacy and safety of adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TIL) in patients with advanced pre-treated non-small cell lung cancer (NSCLC).
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria12
- Active central nervous system (CNS) metastases. Patients with stable CNS metastases ≥ 1 month after definitive treatment (eg, surgery and/or radiotherapy) are eligible.
- Participants with an active second malignancy.
- 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.
- 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.
- 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.
- 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.
Interventions
The study procedures are: * Tumor collection: Study-specific intervention (eg, surgical resection and/or biopsy) to collect tumor material from one or more tumor lesions/metastases for the generation of the TIL product (tumor-infiltrating lymphocytes, TILs). * TIL expansion: Production of the TIL product in the Good-Manufacturing-Practice (GMP) Facility for Advanced Therapies of the University Hospital of Basel. * Lymphodepleting chemotherapy (lymphodepletion): Chemotherapy with cyclophosphamide and fludarabine (day -7 until day -3). * TIL transfer: Infusion of the TIL product back to the patient. TIL transfer is scheduled on day 0. * Interleukin-2 (IL-2) therapy: Therapy with high-dose IL-2 (Aldesleukin) every 8 hours for up to 15 doses. IL-2 therapy starts on day 0.
Locations(1)
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NCT06455917