A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor (GUARDIAN)

April 24, 2025 updated by: Tianjin Medical University Cancer Institute and Hospital

The Phase I, Open-label, Single-arm Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Patients With Advanced Solid Tumors

This study is a Phase I, open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  1. Ability to understand and sign a written informed consent document；
  2. At the date of signing ICF, 18 ~70 years old, male or female；
  3. Histopathological confirmed advanced solid tumor patients who have failed to standard treatment or intolerance with standard treatment；
  4. There is at least one resectable tumor lesion that has not received radiation therapy or other local therapies;
  5. At least one measurable lesion at baseline per RECIST version 1.1；
  6. The expected survival time is more than 12 weeks;
  7. ECOG 0-1 points;
  8. Adequate organ functions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GK01 injection
Autologous tumor-reactive T cells injection
Drug: GK01 Injection
Autologous tumor-reactive T cells injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 2 years
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 2 years
2 years
Disease control rate (DCR)
Time Frame: 2 years
2 years
PK
Time Frame: 2 years
Levels of T-cell Receptor copies
2 years
Progress-free survival(PFS)
Time Frame: 2 years
PFS will be assessed from the first GK01 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)
2 years
Overall survival (OS )
Time Frame: 2 years
OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria)
2 years
Patient Quality of Life
Time Frame: 2 years
EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30)
2 years
PD marker
Time Frame: 2 years
Concentration levels of serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Beijing Geek Gene Technology Co., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

March 18, 2028

Study Completion (Estimated)

July 18, 2028

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GK01IIT-TZ01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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