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Clinical Trial Summary

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.


Clinical Trial Description

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 1. To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation. 2. To identify lymphocyte clonal populations in the tissue that are specific for tumor cells 3. To identify immune reconstitution in the peripheral blood shaped by ALI. 4. To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04668833
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 29, 2020
Completion date February 2, 2027

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