RecruitingEarly Phase 1NCT06077903

GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors

A Single Center, Single Arm Phase I Clinical Study of GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors

Sponsor

Grit Biotechnology

Enrollment

20 participants

Start Date

Jul 5, 2021

Study Type

INTERVENTIONAL

Conditions

Adult

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

\. 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 Criteria5

\. 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;
\. Patients who have refractory or intractable epilepsy, active gastrointestinal bleeding or IL-2 contraindications;
\. 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);

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