Status:
RECRUITING
GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors
Lead Sponsor:
Grit Biotechnology
Conditions:
Adult
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief 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 i...
Eligibility Criteria
Inclusion
- 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;
- Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
- 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 ≥1cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
Exclusion
- 1\. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
- 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;
- 3\. Patients who have refractory or intractable epilepsy, active gastrointestinal bleeding or IL-2 contraindications;
- 4\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
- 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);
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06077903
Start Date
July 5 2021
End Date
July 1 2025
Last Update
February 21 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000