drugset / Trial / NCT05122221

CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

NCT05122221 ↗

Phase 1 Unknown 12 enrolled Corregene Biotechnology Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.

Timeline

Start
2022-07-17
Primary completion
2023-03
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CRTE7A2-01 TCR-T Cell Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 —
Background Fludarabine Small molecule 25 mg/m2 —
Background aldesleukin Protein / enzyme biologic 2e+07 iu —