This phase II trial studies the effect of autologous lymphocyte infusions after standard of care chemotherapy and/or radiation therapy on white blood cell count in patients with stage II-IVA non-small cell lung cancer or esophageal cancer. White blood cells fight infection and may kill tumor cells. Chemotherapy and radiation therapy may damage or destroy the white blood cells in blood. Apheresis is the procedure for collecting white blood cells. Giving white blood cells to patients after standard of care chemotherapy and radiation may help prevent infections and improve cancer treatment outcome. The goal of this trial is to learn if collecting patients’ white blood cells before standard of care chemotherapy and radiation therapy and then giving patients those white blood cells after chemotherapy and radiation therapy may help treat patients with non-small cell lung cancer or esophageal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04668833.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. 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:
I. To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation.
II. To identify lymphocyte clonal populations in the tissue that are specific for tumor cells
III. To identify immune reconstitution in the peripheral blood shaped by ALI.
IV. To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.
OUTLINE:
Patients undergo apheresis over 3 hours. Patients then receive chemotherapy and/or undergo radiation therapy per standard of care according to the discretion of the treating medical oncologist. Within 3 days after the last radiation treatment, patients receive autologous lymphocytes intravenously (IV) over 1 hour.
After completion of study treatment, patients are followed up for up to 42 days from date of ALI.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorGheath Al-Atrash
