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Trial Title:
Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of Advanced Solid Tumors (Gynecological Tumors)
NCT ID:
NCT06145802
Condition:
Solid Tumor
Gynecological Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GT316
Description:
Autologous Tumor Infiltrating Lymphocyte Injection
Arm group label:
GT316 treatment group
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 lung-clearing pretreatment period, a treatment and
observation period, and a follow-up period.
Criteria for 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.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 the first dose of
this study, 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);
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Tenth People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongping Cheng, PHD
Phone:
+86 13816686812
Email:
mdcheng18@263.net
Start date:
March 9, 2023
Completion date:
March 9, 2026
Lead sponsor:
Agency:
Grit Biotechnology
Agency class:
Industry
Source:
Grit Biotechnology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06145802
