drugset / Trial / NCT05357027

HPV16 E6 TCR T Cells for Cervical Carcinoma

NCT05357027

Phase 1/2 Terminated 5 enrolled TCRCure Biopharma Ltd. Fudan University · collab
NaSingle-groupOpen-labelTreatment

Summary

Background: Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection. Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting HPV E6. The genetically engineered cells are called E6 TCR-T cells. The engineered cells are re-infused in the patients with cervical carcinoma. Objective: To evaluate the safety and efficacy of TCR-T cells in the treatment of cervical carcinoma. Eligibility: Adults aging 18-70 with relapsed/refractory to standard treatment or metastatic cervical carcinoma. Design: Patients will have many screening tests, including imaging procedures, heart and lung tests, and lab tests. Patients will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Engineered T cells will be re-infused into the patients will stay in hospital and be evaluated.

Timeline

Start
2022-08-10
Primary completion
2026-01-15
Completion
2026-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject TC-E202 Cell therapy
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule
Background aldesleukin Protein / enzyme biologic

Indications