Experimental cell therapy for advanced gynecological cancers halted before start
NCT ID NCT06145802
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test an experimental treatment called GT316, made from a patient's own immune cells (tumor-infiltrating lymphocytes), for advanced gynecological cancers. The goal was to check the safety and side effects of this cell therapy. However, the study was withdrawn before any participants were enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Started
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Mar 2023
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor; * 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues ≥1.0cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible; Exclusion Criteria: * 1\. Subjects with ≥3 untreated CNS metastases at screening (If the subject has ≤3 CNS metastases with a maximum diameter of \<1cm, and there is no peritumor edema on brain imaging (MRI or CT).no evidence of progressive CNS disease on brain imaging at least 3 months after treatment, then subjects will be included.); * 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone); * 3\. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring * 4\. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis,pericardial effusion, active gastrointestinal bleeding or IL-2 contraindications; * 5\. 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 * 6\. Patients who have received allogeneic bone marrow transplantation or an organ allograft; * 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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