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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06954558

Acronym

GUARDIAN

Enrollment

Registered

2025-05-01

Start date

2025-03-18

Completion date

2028-07-18

Last updated

2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

efficacy, safety, PK, TILs

Brief summary

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.

Interventions

DRUGGK01 Injection

Autologous tumor-reactive T cells injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactJihui Hao

haojihui@tjmuch.com+86-02223340123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026