NCT05681780View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 10, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Non Small Cell Lung CancerStage IV Non-small Cell Lung CancerRecurrent Non Small Cell Lung Cancer
Interventions
BIOLOGICAL

Tumor-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.

DRUG

Nivolumab

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.

DRUG

Cyclophosphamide

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

DRUG

Fludarabine

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

OTHER

Tumor-infiltrating Lymphocyte Therapy

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

DRUG

Interleukin-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.

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER