Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 28, 2021

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2027

Conditions
Epithelial Tumors, MalignantMalignant Solid Tumor
Interventions
BIOLOGICAL

NEXTGEN-TIL

"NEXTGEN-TIL product is a cellular investigational product comprising a live cell suspension of autologous tumor-infiltrating lymphocytes derived from the patient's own tumor.~Each dose contains at least 5 x 10\^8 total viable lymphocytes, and a maximum of 1.11x10\^11. It will be administered IV on Day 0 (24h after the last dose of Fludarabine)."

DRUG

Non-myeloablative Lymphodepletion (NMA-LD) Regimen

Patients will receive a NMA-LD chemotherapy based on Cyclophosphamide 60 mg/kg IV (once daily on Days -5 and -4) and Fludarabine 25 mg/m2 IV (once daily on Days -5 to -1).

DRUG

Interleukin-2

"Patients will receive sequential doses of 720,000 IU/kg IV IL-2 every 8-24 hours depending on patient tolerance. It will be administered on Days 0 to 2, starting between 3 and 24 hours after the completion of NEXTGEN-TIL infusion.~IL-2 doses may be skipped in case of toxicity. If 2 sequential doses or more than 2 non-sequential doses of IL-2 are skipped due to patient intolerance or the discretion of the investigator, IL-2 administration must be stopped."

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