drugset / Trial / NCT03935893
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |