To hear about similar clinical trials, please enter your email below
Trial Title:
GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors
NCT ID:
NCT06077903
Condition:
Adult
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:
GT101
Description:
Autologous tumor infiltrating lymphocyte injection
Arm group label:
GT101 treatment group
Summary:
This study is a single center, single arm phase I clinical trial. This study proposes to
enroll 20 subjects, with a trial protocol including chemotherapy pretreatment, reinfusion
of autologous tumor infiltrating lymphocyte injection, and interleukin-2 injection.
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 mass Volume ≥0.5cm^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 who have symptomatic and/or untreated CNS metastases (Except stable
brain metastases, no medication required within 2 weeks, no hormone
dependence);
- 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 5 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 who have refractory or intractable epilepsy, active gastrointestinal
bleeding or IL-2 contraindications;
-
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:
3 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Zhang, PHD
Phone:
+86-0371-66295320
Email:
yizhang@zzu.edu.cn
Start date:
July 5, 2021
Completion date:
July 2024
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/NCT06077903
