Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer

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 wi

Trial Details

NCT ID

NCT06530303

Phase

PHASE1 / PHASE2

Sponsor

Essen Biotech

Status

RECRUITING

Cancer Type

Colon Cancer Colorectal Cancer

Interventions

Tumor Infiltrating Lymphocytes (TIL)
Cyclophosphamide
Fludarabine
Interleukin-2
Pembrolizumab

Locations (sample)

Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

Age: 16 years to 90 years
Histologically diagnosed as primary/relapsed/metastasized Cancer
Expected life span more than 3 months
Karnofsky≥60% or ECOG score 0-2

For full eligibility, visit ClinicalTrials.gov.

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