Lung Cancer Clinical Trial
ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter
The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective.
The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation. Primary Objective To investigate the preliminary efficacy of autologous lymphocyte infusion (ALI) in improving the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemo-radiation (CRT). Secondary Objectives
To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation.
To identify lymphocyte clonal populations in the tissue that are specific for tumor cells
To identify immune reconstitution in the peripheral blood shaped by ALI.
To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.
Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18
Prior radiotherapy to the chest Life expectancy<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy
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