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Single Arm Phase I Trail of Autologous Tumor Infiltrating Lymphocyte Injection (GT202) in the Treatment of Metastatic or Recurrent Gynecological Tumors

NCT05238818 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-02-14

No results posted yet for this study

Summary

A prospective, open-label, non-randomized, Phase 1 study evaluating autologous tumor infiltrating lymphocyte injection (GT202) in the treatment of metastatic or recurrent Gynecological tumors.

Conditions

  • Metastatic or Recurrent Gynecological Tumors

Interventions

BIOLOGICAL

Autologous Tumor Infiltrating Lymphocyte Injection (GT202)

A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. T cells then are manufactured to express mbIL-12. After lymphodepletion, patients are infused with GT202 followed by IL-2.

Sponsors & Collaborators

  • XinWu

    lead OTHER

Principal Investigators

  • xin wu, PHD · The Obstetrics and Gynecology Hospital of 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
2022-03-31
Primary Completion
2024-01-31
Completion
2025-01-31

Countries

  • China

Study Locations

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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 NCT05238818 on ClinicalTrials.gov