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Using immune cells to treat recurrent or metastatic cervical cancer

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

Phase 2 Interventional Grit Biotechnology · NCT06241781

This study is testing if a new immune cell treatment can work better than a standard chemotherapy drug for people with recurrent or metastatic cervical cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment83 (estimated)
Ages18 Years to 70 Years
SexFemale
SponsorGrit Biotechnology Industry-sponsored
Locations24 sites (Beijing, Beijing Municipality and 23 other locations)
Trial IDNCT06241781 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the effectiveness and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared to Gemcitabine in patients with recurrent or metastatic cervical cancer. The study is multicenter, open-label, and randomized, allowing for a direct comparison between the two treatment options. Participants must have previously received systemic therapy and meet specific health criteria to ensure their eligibility for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with unresectable recurrent or metastatic cervical cancer who have received at least one prior systemic therapy.

Not a fit: Patients with early-stage cervical cancer or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with recurrent or metastatic cervical cancer.

How similar studies have performed: While this approach is innovative, similar studies using tumor-infiltrating lymphocytes have shown promise in other cancers, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Beijing, Beijing Municipality and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions Adult
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.