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HPV16 E6 TCR T Cells for Cervical Carcinoma

NCT05357027 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Cervical Carcinoma

Interventions

BIOLOGICAL

TC-E202 cells

T cells genetically engineered with a TCR targeting HPV16 E6 (E6 TCR) that display specific reactivity against HLA-A2+, HPV-16+ target cells

DRUG

IL-2

Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance. IL-2 improves the survival of TC-E202 cells after infusion.

DRUG

Fludarabine

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

DRUG

Cyclophosphamide Capsules

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • TCRCure Biopharma Ltd.

    lead INDUSTRY

Principal Investigators

  • XiaoHua Wu, doctor · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357027 on ClinicalTrials.gov