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Trial Title:
Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors
NCT ID:
NCT06094426
Condition:
Solid Tumor
Adult
GT316
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group 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 trial is a multicenter, single-arm, open design designed to evaluate the safety and
tolerability of Autologous Tumor Infiltrating Lymphocyte Injection in the treatment of
patients with advanced solid tumors, as well as pharmacokinetic profiling and efficacy.
The trial consists of two phases: dose-escalation and dose-expansion.
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.Patients with ≥3 untreated CNS metastases at the time of screening (patients were
included if they had ≤3 CNS metastases with a maximum diameter of <1 cm and no
peritumor edema on brain imaging (MRI or CT) and no evidence of progressive CNS
disease on brain imaging for at least 3 months after treatment)
- 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.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;
- 5.Patients with refractory or intractable epilepsy, drug-uncontrolled pleural
effusion, abdominal effusion, pericardial effusion, active gastrointestinal bleeding
or contraindications to IL-2;
-
6. 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；
-
7. Patients who have received allogeneic bone marrow transplantation or an organ
allograft;
- 8.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:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Zhang, PHD
Phone:
+86-0371-66295320
Email:
yizhang001@163.com
Start date:
February 26, 2023
Completion date:
February 26, 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/NCT06094426
