Status:
RECRUITING
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Lead Sponsor:
Grit Biotechnology
Conditions:
Solid Tumors, Adult
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observ...
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 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
- 1\. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
- 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;
- 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;
- 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 :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05430373
Start Date
May 23 2022
End Date
December 31 2025
Last Update
February 7 2025
Active Locations (5)
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1
The fifth medical center of the General Hospital of the Chinese people's Liberation Army
Beijing, Beijing Municipality, China, 100039
2
Chongqing University Cancer Center
Chongqing, Chongqing Municipality, China, 400030
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
4
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610064