NCT01946373

T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Melanoma

A Phase I Study to Evaluate Safety, Feasibility and Immunologic Response of Adoptive T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Metastatic Melanoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn if dendritic cell vaccine will increase the effect of tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with melanoma.

Detailed description

The MAT02 clinical trial is a phase 1 clinical trial with the objective to assess the safety, feasibility and immunological efficacy of the combined application of two immunological treatment modalities in patients with metastatic melanoma: 1. Cohort A: After a non-myeloablative conditioning regimen, 5 patients will receive one bulk infusion of T cells. T cells will be expanded ex vivo from autologous tumor infiltrating lymphocytes (TIL). In vivo persistence of the infused cells will be supported by administration of IL-2, a T cell survival factor. 2. Cohort B: This adoptive cell transfer (ACT) step will in additional 10 patients be followed by a vaccination with autologous, in vitro-generated, dendritic cells (DC), loaded with autologous tumor lysate and a synthetically produced peptide derived from the tumor associated antigen NY-ESO 1.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide
DRUG	Fludarabine
BIOLOGICAL	T cells
BIOLOGICAL	Interleukin-2
BIOLOGICAL	Dendritic cell vaccine

Timeline

• Start date: 2013-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2013-09-19
• Last updated: 2022-10-04

Locations

1 site across 1 country: Sweden