Evaluation of a Pragmatic Approach to Adoptive Cell Therapy (ACT) Using an IL2 Analog (ANV419) vs High Dose IL2 After Tumor Infiltrating Lymphocytes (TIL) Therapy in Patients With Melanoma, NSCLC and Cervical Cancer (PragmaTIL)

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2029

Conditions
MelanomaNon Small Cell Lung CancerCervical Cancer
Interventions
BIOLOGICAL

NMA-LD regimen

The use of the NMA-LD regimen (cyclophosphamide and fludarabine) prior to cell administration is expected to lead to myelosuppression in all patients.

BIOLOGICAL

Tumor infiltrating lymphocytes adoptive cell therapy (TIL-ACT) infusion

On Day 0 (at least 24h after the last dose of fludarabine) patients will be hospitalized in a dedicated unit. Autologous TIL infusion will be administered intravenously.

BIOLOGICAL

High dose IL-2

"Only for patients in Arm A.~IL-2 begins between 3 and 24 hours after the completion of the TIL infusion and is given as a bolus administration every eight hours (minimum interval) to 24 hours (maximum interval) with a maximum of six doses from the beginning of each administration."

BIOLOGICAL

IL-2 analog

"Only for patients in Arm B~ANV419 will be administered between 3 and 24 hours after the completion of the TIL infusion with a slow IV infusion over 15-30 minutes + 5 minutes once, at 243µg/kg."

Trial Locations (1)

Unknown

RECRUITING

Vall d'Hebron Institute of Oncology, Barcelona

All Listed Sponsors
collaborator

Banc de Sang i Teixits

OTHER

lead

Vall d'Hebron Institute of Oncology

OTHER