Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06241781

Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Fifth Medical Center of the General Hospital of the People's Liberation Army of China, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GT101 injection

Biological

GT101 injection to treat cervical cancer

Gemcitabine injection

Drug

Gemcitabine injection to treat cervical cancer

Primary outcomes

  1. Progression Free Survival

    Time frame: 3 years

    Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.

Secondary outcomes

  1. Duration of Response

    Time frame: 3 years

    Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: 3 years

    Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Wang, PHD

CONTACT

[email protected]

XiaoHua Wu, PHD

CONTACT

[email protected]

021-64175590

Sponsors and collaborators

Lead sponsor

Grit Biotechnology

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.