RecruitingPhase 1NCT05681780

Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

20 participants

Start Date

Mar 10, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer

Summary

To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a drug called Fludarabine, and others for people with non-small cell lung cancer, recurrent non-small cell lung cancer, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTumor-infiltrating Lymphocytes (TIL)

Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.

DRUGNivolumab

Nivolumab (Opdivo®), 360 mg, IV infusion every 3 weeks prior to TIL infusion, and then after TIL infusion 480 mg ever 4 weeks for up to 12 months.

DRUGCyclophosphamide

Cyclophosphamide will be administered on days -7 and -6.

DRUGFludarabine

Fludarabine will then be infused per institutional standard on Days -7 to -3.

OTHERTumor-infiltrating Lymphocyte Therapy

On day 0, all patients will receive a dose infusion TIL cells.

DRUGInterleukin-2 (IL2)

Participants will receive IL-2 for up to 6 doses, based on participants tolerance and investigator judgement. This will be given after the infusion of the T-cells.