drugset / Trial / NCT01462903

A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors

NCT01462903

Phase 1 Unknown 20 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

Background: T cell based adoptive immunotherapy including CTL and TIL may stimulated the immune system and stop cancer cells from growing. Objective: Phase I clinical trial to investigate the toxicity and immune response of therapy with autologous tumor infiltrating lymphocytes as adjuvant treatment for metastatic nasopharyngeal carcinoma and hepatocellular carcinoma after primary operation, radiotherapy and chemotherapy. Methodology: Phase I clinical trial in patients with advanced nasopharyngeal carcinoma, hepatocellular carcinoma, breast cancer and other solid cancers. The investigators isolated lymphocytes from fresh tumor tissues, activated and expanded TILs in vitro; and infused the enough number (10e9 to 10e10) of TIL back patients.

Timeline

Start
2011-09
Primary completion
2014-11
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+09 cells Intravenous
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+10 cells Intravenous
Background aldesleukin Protein / enzyme biologic 2e+06 iu Subcutaneous