drugset / Trial / NCT03935893

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

NCT03935893

Phase 2 Active not recruiting 20 enrolled Udai Kammula
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2 study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options by using the objective response rate (ORR).

Timeline

Start
2019-12-03
Primary completion
2037-06-30
Completion
2038-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+09 cells Intravenous
Subject Tumor Infiltrating Lymphocytes Cell therapy 2e+11 cells Intravenous
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule