Summary
This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy
Official Title
A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas
Details
This study will be conducted in 2 parts:
The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.
The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.
Keywords
HPV-Related Squamous Cell Carcinoma, HPV-Related Cervical Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vaginal Squamous Cell Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Head and Neck Cancer, Human Papilloma Virus, HPV, Cervical Cancer, Head and Neck Cancer, Oropharyngeal Cancer, Vulvar Cancer, Vaginal Cancer, Penile Cancer, Anal Cancer, Anogenital Cancer, TCR T Cell, Cell therapy, T cell receptor T cell, Carcinoma, Squamous Cell Carcinoma, Head and Neck Neoplasms, Cyclophosphamide, Fludarabine, SCG142, SCG142 T cells