A Phase 1 Study of RTX-321 for the Treatment of Patients with Advanced Malignancies Associated with Human Papillomavirus-16 Infection

Brief description of study

The purpose of the study is to determine the safety and tolerability of RTX-321 for the treatment of patients that are HLA-A*02:01 (a major histocompatibility complex class I [MHC I]) positive with persistent, recurrent, or metastatic, unresectable, HPV 16+ cancers. RTX-321 is a cellular therapy consisting of allogeneic, cultured, human, enucleated red cells. The study drug RTX-321 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01513
ClinicalTrials.gov Identifier: NCT04672980
Principal Investigator: Paul E. Oberstein.


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