GT201 Injection For The Treatment Of Advanced Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:

A Single-Arm Phase I/II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) for The Treatment Of Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144671
• Other study ID #: GT-CD-CHN-201-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 13, 2023
• Est. completion date: September 13, 2026

Study information

• Verified date: October 2023
• Source: Grit Biotechnology
• Contact: Yongsheng Wang, PHD
• Phone: +86 18980602258
• Email: wangys[@]wchscu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3 dose groups.A modified "3+3" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional "3+3" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional "3+3" dose-escalation principle,The second and third dose groups are based on the traditional "3+3" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 13, 2026
• Est. primary completion date: September 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;
• 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 =1.0cm^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.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);
• 2. Arterial/venous thrombotic events within 3 months prior to enrollment, such as:

cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;

• 3. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;
• 4. Participate in other clinical trials within 4 weeks prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same;
• 5. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• 6.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).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• GT201
Autologous tumor infiltrating lymphocyte injection

Locations

Country	Name	City	State
China	The fifth medical center of the General Hospital of the Chinese people's Liberation Army	Beijing	Beijing
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Shandong Cancer Hospital	Jinan	Shandong
China	Union Hospital Tongji Medical College Huazhong University Of Science And Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Grit Biotechnology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile Measured By Grade = 3 TREAs	Safety Profile Measured By Grade = 3 TREAs for CTCAE 5.0	3 years
Secondary	Tumor imaging to determine changes in tumor size	Tumor imaging determines the changes in tumor size at baseline and after treatment.Tumor imaging evaluation according to RECIST v1.1	3 years