NCT04677361

Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab

A Pilot Study to Assess the Feasibility of Expanding Marrow Infiltrating Lymphocytes (MILs™) From Bone Marrow in Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) and Subsequently the Efficacy and Safety of MILs™ in Combination With Pembrolizumab in Patients With NSCLC and SCLC

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• SCLC
• NSCLC

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MILs™ in Combination with Pembrolizumab	Efficacy and Safety of MILs™ in Combination with Pembrolizumab in Patients with NSCLC and SCLC

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-10-01
• Completion: 2024-10-01
• First posted: 2020-12-21
• Last updated: 2021-10-08

Regulatory

• FDA-regulated drug study