GT201 Injection For The Treatment Of Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: GT201

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yongsheng Wang, PHD; Phone Number: +86 18980602258; Email: wangys@wchscu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • The fifth medical center of the General Hospital of the Chinese people's Liberation Army
      • Contact: Haifeng Qing; Phone Number: +86 13601365243; Email: hifo@263.net
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Contact: Xiaorong Dong, PHD; Phone Number: +86 13986252286; Email: xhzzdxr@126.com
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: Yuping Sun, PHD; Phone Number: +86 13370582181; Email: 13370582181@163.com
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • West China Hospital Sichuan University
      • Contact: Yongsheng Wang, PHD; Phone Number: +86 18980602258; Email: wangys@wchscu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GT201 treatment group; GT201 5E9（5×10^9）;GT201 1E10（1×10^10）;GT201 5E10（5×10^10）.	Drug: GT201; Autologous tumor infiltrating lymphocyte injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Profile Measured By Grade ≥ 3 TREAs	Safety Profile Measured By Grade ≥ 3 TREAs for CTCAE 5.0	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Grit Biotechnology

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): September 13, 2026

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GT-CD-CHN-201-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No