Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing GT101 for Recurrent or Metastatic Cervical Cancer

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

Official registry: https://clinicaltrials.gov/study/NCT06241781 · Grit Biotechnology · enrollment listed as 100

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are GT101, Gemcitabine injection, or IL-2. The registry lists allocation as randomized. This is a Phase II, multicenter, open-label, randomly assigned, parallel group, treatment study to assess the how well it works and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.

They plan to enroll about 100 people at 38 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: GT101, Gemcitabine injection, IL-2

Primary outcome (registry wording): Progression Free Survival (PFS) (per RECIST V.1.1) by IRC assessment

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • Women only
  • 2\. Aged ≥18 years and ≤70 years
  • 3\. Recurrent or metastatic cervical cancer: have received prior adequate first-line systemic therapy with radiologically confirmed disease progression during or after treatment
  • 4\. Have at least one resectable tumor lesion for the manufacture of autologous tumor-infiltrating lymphocytes (TILs)
  • 5\. Apart from the sampling lesion(s), have at least one measurable lesion per RECIST 1.1
  • 6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 7\. Expected survival ≥12 weeks
  • 8\. Adequate normal organ and bone marrow function

Public study contact (from the registry)

XiaoHua Wu, PHD

+86-21-64175590

wu.xh@fudan.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

38 listed

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FAQ about this NCT record

Is NCT06241781 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06241781?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06241781?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary