Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of … (NCT06145802) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of Advanced Solid Tumors (Gynecological Tumors)
Stopped: The study was terminated from a business perspective.
0Started 2023-03-09
Plain-language summary
This study is a single-arm, open clinical trial.This trial consists of two phases, dose-escalation and expansion, and the study process is divided into: a screening period, a sampling and production period, a NMA-LD chemotherapy period, a treatment and observation period, and a follow-up period.
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.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 predn…
What they're measuring
1
Incidience and severity of adverse events per CTCAE 5.0