Marrow infiltrating lymphocytes (MILs™) are a novel method of adoptive cell therapy that provide an activated, polyclonal population of autologous tumor-specific T cells derived from the bone marrow. MILs™ in this study will be used to treat small cell lung cancer (SCLC) that has become resistant to chemotherapy and radiation.
Small cell lung cancer (SCLC) is generally treated with surgery or chemotherapy, with or without radiation therapy, depending on staging. The problem with current available treatments is that SCLC almost always becomes resistant to chemotherapy and radiation. Marrow infiltrating lymphocytes (MILs™) are a novel method of adoptive cell therapy that provide an activated, polyclonal population of autologous tumor-specific T cells derived from bone marrow. Prior to treatment of MILs™ patients will receive non-myeloablative lymphodepletion with cyclophosphamide and fludarabine to increase the efficacy of adoptive T cell therapy. Bone marrow aspirate (BMA) will be collected from the patient to manufacture the MILs™. Upon progression and after the bone marrow is collected, a subject may receive bridging treatment of pembrolizumab until the MILs™ are received, after which treatment of the MILs™ and pembrolizumab will begin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Efficacy and Safety of MILs™ in Combination with Pembrolizumab in Patients with NSCLC and SCLC
Assess the safety of infusion of MILs™ by Adverse Events per
To assess the safety and tolerability of MILs™ in patients with NSCLC and SCLC
Time frame: 2 years
Progression free survival (PFS) in patients as the length of time from the day of MILs™ administration to progression of the disease
To determine the efficacy per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of MILs™ + pembrolizumab administration in patients with NSCLC and SCLC
Time frame: 2 years
Overall response rate (ORR) as the portion of patients with a tumor size reduction from the time of MILs™ administration to the time first response is seen in patients, whether it is partial response (PR) or complete response (CR
To determine the efficacy per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of MILs™ + pembrolizumab administration in patients with NSCLC and SCLC
Time frame: 2 years
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