A Phase II Trial of Adoptive Cell Therapy With Tumor-infiltrating Lymphocytes in Patients With Non-Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
Department of Medical Oncology, University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
David König, Dr. med.
david.koenig@usb.ch
+41 61 265 5074
Backup
Heinz Läubli, Prof. Dr. med.
heinz.laeubli@usb.ch
+41 61 265 5074
Time Frame
Start Date: 2025-01-22
Estimated Completion Date: 2029-12
Participants
Target number of participants: 30
Treatments
Experimental: Tumor-infiltrating lymphocyte product (TIL) transfer
Tumor-specific T cells are expanded from excised tumor samples and stimulated in cell culture with interleukin-2 (IL-2). The resulting autologous TILs are then re-infused to the patient after a non-myeloablative lymphodepleting chemotherapy with cyclophosphamide and fludarabine. Activation of TILs in the patient is then supported by IL-2 administration. The transplant product will be produced in the Good Manufacturing Practice (GMP) facility of the University Hospital in Basel.
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov