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Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer
Sponsor: Essen Biotech
Summary
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response, while Aldesleukin will be used to further stimulate the TILs. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
Official title: Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Immunotherapy in Patients With Advanced or Metastatic Refractory Colon and Rectal Cancer (Colorectum)
Key Details
Gender
All
Age Range
16 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2024-09-29
Completion Date
2026-12-28
Last Updated
2024-11-05
Healthy Volunteers
No
Interventions
Tumor Infiltrating Lymphocytes (TIL)
Tumor Infiltrating Lymphocytes (TIL) IV
Cyclophosphamide
Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.
Fludarabine
Fludarabine will be administered as an intravenous (IV) infusion for five days.
Interleukin-2
After TIL infusion, IL-2 will be started as a bolus administration every eight hours, for a maximum of eight doses.
Pembrolizumab
Intravenous (IV) infusion
Locations (1)
District One Hospital
Beijing, Beijing Municipality, China