NCT06241781 Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
| NCT ID | NCT06241781 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Grit Biotechnology |
| Condition | Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 83 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 83 participants in total. It began in 2024-04-02 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06241781 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06241781 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06241781 currently recruiting?
Yes, NCT06241781 is actively recruiting participants. Contact the research team at wu.xh@fudan.edu.cn for enrollment information.
Where is the NCT06241781 trial being conducted?
This trial is being conducted at Beijing, China, Fuzhou, China, Shenzhen, China, Guilin, China and 11 additional locations.
Who is sponsoring the NCT06241781 clinical trial?
NCT06241781 is sponsored by Grit Biotechnology. The trial plans to enroll 83 participants.