NCT05681780

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-10
• Primary completion: 2026-06-01
• Completion: 2027-12-01
• First posted: 2023-01-12
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study