GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
NCT ID: NCT05430373
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
31 participants
INTERVENTIONAL
2022-05-23
2025-12-31
Brief Summary
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The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes：
1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).
2. GT101 infusion.
3. post-infusion treatment (interleukin-2 intravenous push).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GT101 treatment group
Autologous tumor infiltrating lymphocyte injection
GT101
Autologous tumor infiltrating lymphocyte injection
Interventions
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GT101
Autologous tumor infiltrating lymphocyte injection
Eligibility Criteria
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Inclusion Criteria
* 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 weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
Exclusion Criteria
* 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 6 months prior to surgical operation, 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, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
* 6\. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same time;
* 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);
18 Years
70 Years
ALL
No
Sponsors
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Grit Biotechnology
INDUSTRY
Responsible Party
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Locations
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The fifth medical center of the General Hospital of the Chinese people's Liberation Army
Beijing, Beijing Municipality, China
Chongqing University Cancer Center
Chongqing, Chongqing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Dongmei Ji, PhD
Role: backup
Other Identifiers
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GT101-101
Identifier Type: -
Identifier Source: org_study_id
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