drugset / Trial / NCT06151847
Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma
Phase 2
Completed
11 enrolled
University of Kansas Medical Center
Iovance Biotherapeutics, Inc. · collabNational Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.
Timeline
- Start
- 2023-12-21
- Primary completion
- 2025-07-10
- Completion
- 2025-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | — | Intravenous |