Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors
Trial Parameters
Brief Summary
Multicenter, single arm, non-randomized, prospective, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (BEN101) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic solid tumor.
Eligibility Criteria
Inclusion criteria 1. Be able and willing to provide written informed consent, and to comply with all requirements of study participation (including all study procedures). 2. Age: 18 - 75 years. 3. Histological or cytological diagnosis of advanced metastatic solid tumors. 4. Progression on standard therapy, or intolerance to, refusal or unable to benefit from standard therapy according to investigator's judgement. 5. At least one resectable lesion (or aggregate of lesions) of a minimum 15 mm in diameter post-resection; or core biopsy (aggregate of around 1 gram or two 18G puncture needles). 6. At least one measurable target lesion, as defined by RECIST v1.1.Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to screening, and there has been demonstrated disease progression in that particular lesion. 7. ECOG performance status of 0 or 1. 8. Life expectancy of at least 3 months. 9. Adequate organ