A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Grit Biotechnology43 sites in 1 country83 target enrollmentApril 2, 2024

ConditionsAdult

InterventionsGT101 injection Gemcitabine injection

DrugsGT101 injection Gemcitabine injection

Overview

Phase: Phase 2
Intervention: GT101 injection
Conditions: Adult
Sponsor: Grit Biotechnology
Enrollment: 83
Locations: 43
Primary Endpoint: Progression Free Survival
Status: Recruiting
Last Updated: 17 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.

Registry

clinicaltrials.gov

Start Date

April 2, 2024

End Date

January 31, 2027

Last Updated

17 days ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Grit Biotechnology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) ,must have the ability to understand the requirements of the study);
•2\. The patient must be 18 to 70 years of age at the time of consent;
•3\. Must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy;
•4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
•5\. Expected survival time of ≥ 12 weeks;
•6\. Adequate normal organ and marrow function;
•7\. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented.
•8.Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).

Exclusion Criteria

•1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
•2.Patients who have psychiatric disorders, alcohol, drug or substance abuse;
•3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;
•4.Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time;
•5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.