Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer) (NCT06191900) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (Advanced Cervical Cancer)
Stopped: The study was terminated from a business perspective.
China4 participantsStarted 2023-06-05
Plain-language summary
This study is an early exploration clinical study with one arm.
The study consists of two stages, namely the dose escalation stage and the dose extension stage:
Who can participate
Age range18 Years – 70 Years
SexALL
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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.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 mass weighing ≥1.0g (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.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);
* 2\. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
* 3.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
* 4\. Patients who have received allogeneic bone…
What they're measuring
1
Incidence and severity of adcersed events per CTCAE 5.0