GT201 Injection For The Treatment Of Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Solid Tumor, Adult
• Interventions: Drug: GT201

• Registration Number: NCT06144671
• Lead Sponsor: Grit Biotechnology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-22
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Primary Completion: 2026-09-13
• Study Completion: 2026-09-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GT201 treatment group	GT201	GT201 5E9（5×10\^9）;GT201 1E10（1×10\^10）;GT201 5E10（5×10\^10）.

Primary Outcome Measures

Name	Time	Method
Safety Profile Measured By Grade ≥ 3 TREAs	3 years	Safety Profile Measured By Grade ≥ 3 TREAs for CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
Tumor imaging to determine changes in tumor size	3 years	Tumor imaging determines the changes in tumor size at baseline and after treatment.Tumor imaging evaluation according to RECIST v1.1

Trial Locations

Locations (4)

The fifth medical center of the General Hospital of the Chinese people's Liberation Army; 🇨🇳 Beijing, Beijing, China

Union Hospital Tongji Medical College Huazhong University Of Science And Technology; 🇨🇳 Wuhan, Hubei, China

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China

West China Hospital Sichuan University; 🇨🇳 Chengdu, Sichuan, China