NCT06241781 Autologous Tumor Infiltrating Lymphocytes Injection (GT101 Injection) for the Treatment of Recurrent or Metastatic Cervical Cancer
| NCT ID | NCT06241781 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Grit Biotechnology |
| Condition | Recurrent or Metastatic Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 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 100 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\. Voluntarily enroll in the study, sign the informed consent form, and be willing and able to comply with the study protocol. * 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. * 9\. Serum human chorionic gonadotropin (HCG) test must be negative within 7 days prior to TIL infusion for women of childbearing potential without surgical sterilization. * 10\. Adverse events from prior therapies must have recovered to Grade ≤1 (per CTCAE 5.0) before tumor sampling. * 11\. Participants entering this study due to disease progression must have radiological documentation of disease progression following the last prior treatment before tumor resection. Exclusion Criteria: * 1\. Spinal cord compression not relieved by surgery and/or radiotherapy is exclusionary. * 2\. Uncontrolled tumor-related pain as judged by the investigator. * 3\. Bleeding events occurring within 3 months prior to screening. * 4\. Arterial or venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (DVT), pulmonary embolism (PE), etc. * 5\. Respiratory diseases that substantially impair pulmonary function. * 6\. History of clinically significant cardiovascular disease. * 7\. Participants with untreated central nervous system (CNS) metastatic lesions at screening. * 8\. Active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy. * 9\. Malignancies other than the target indication diagnosed within 5 years before screening. * 10\. Refractory/intractable epilepsy, medically uncontrolled pleural effusion, etc. * 11\. Infectious diseases within 1 year prior to screening. * 12\. Use of anti-angiogenic agents within 4 weeks before sampling. * 13\. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * 14\. Systemic anti-tumor therapy administered within 4 weeks prior to lymphodepleting chemotherapy. * 15\. Prior receipt of genetically modified or edited cellular therapy products. * 16\. History of allergic reaction to any component of the investigational agents to be used in this study. * 17\. Known psychiatric disorders, alcohol abuse, illicit drug use, or substance abuse. * 18\. Prior immunotherapy associated with Grade ≥3 immune-related adverse events (irAEs) that failed to recover to CTCAE Grade 1 or lower within 28 days. * 19\. Pregnant or lactating women, or women planning pregnancy, gestation or lactation within 1 year after cell infusion. * 20\. Receipt of other investigational medicinal products within 4 weeks prior to randomization, or plan to receive other investigational medicinal products during the study. * 21\. Other conditions judged unsuitable for enrollment by 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 Recurrent or Metastatic Cervical Cancer. 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, Beijing, China, Beijing, China, Chongqing, China and 11 additional locations.
Who is sponsoring the NCT06241781 clinical trial?
NCT06241781 is sponsored by Grit Biotechnology. The trial plans to enroll 100 participants.
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