Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT06144671

GT201 Injection For The Treatment Of Advanced Solid Tumors

Led by Grit Biotechnology · Updated on 2026-04-27

18

Participants Needed

4

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

GT201 Injection For The Treatment Of Advanced Solid Tumors

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand study requirements and provide written informed consent
  • Confirmed diagnosis of malignancy by histology or cytology
  • At least one resectable lesion not treated with radiation or local therapies, suitable for tissue collection for lymphocyte preparation
Not Eligible

You will not qualify if you...

  • Active autoimmune disease or history requiring systemic steroid or immunosuppressive therapy (>10 mg/day prednisone or equivalent)
  • Arterial or venous thrombotic events within 3 months prior to enrollment (e.g., stroke, deep vein thrombosis, pulmonary embolism)
  • Refractory or intractable epilepsy, poorly controlled hydrothorax, ascites, pericardial effusion, or contraindications to IL-2
  • Participation in other clinical trials within 4 weeks prior to first dose or planned simultaneous participation
  • Previous allogeneic bone marrow transplant or organ allograft
  • History of hypersensitivity to study drug components including tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, DMSO, human serum albumin, dextran-40, or certain antibiotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

The fifth medical center of the General Hospital of the Chinese people's Liberation Army

Beijing, Beijing Municipality, China

Actively Recruiting

2

Union Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, Hubei, China

Actively Recruiting

3

Shandong Cancer Hospital

Jinan, Shandong, China

Actively Recruiting

4

West China Hospital Sichuan University

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

Y

Yongsheng Wang, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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