A Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.

NCT07412665 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GIMINI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  The incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)

  2 years

Secondary Outcomes (7)

• Pharmacokinetic

  2 years

• Objective response rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

• Duration of Response (DOR)

  2 years

• Progression-free Survival (PFS)

  2 years

Study Arms (1)

GK01 injection

EXPERIMENTAL

Autologous tumor-reactive T cells injection

Drug: GK01 injection

Interventions

GK01 injection DRUG

Autologous tumor-reactive T cells injection

GK01 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and sign a written informed consent document.
• At the date of signing ICF, 18 \~70 years old, male or female.
• Histologically or cytologically confirmed advanced solid tumors, progressed on standard treatment, or intolerant to standard treatment, or without standard treatment; locally recurrent disease must be unsuitable for radical surgical resection or radiotherapy.
• At least one measurable lesion that has not been irradiated or received other local therapies.
• At least one measurable lesion remains (RECIST 1.1 criteria).
• ECOG 0-1 points.
• Expected survival time more than 3 months.
• Adequate hematologic and organ function.
• No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.

You may not qualify if:

• History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).
• Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.
• Extensive field radiotherapy within 28 days prior to ICF signing, exception of local radiotherapy for symptomatic palliation of non-target lesions.
• Major surgery within 28 days prior to signing the ICF, or planned during the study period.
• Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.
• Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.
• History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.
• Prior history of bone marrow or organ transplantation.
• Concurrent or prior history of interstitial lung disease or interstitial pneumonia.
• History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).
• History of other primary malignancies within 5 years prior to the initiation of the study treatment.
• Clinically significant cardiovascular disease.
• History of bleeding within 6 months prior to signing the ICF.
• Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin \[HbA1c\] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and/or uncertainty in survival assessment.
• Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.

Sponsors & Collaborators

• Beijing Geekgene Technology Co., LTD: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (2)

Peking University Cancer Hospital

Beijing, China

Location

Peking University Cancer Hospital

Beijing, China

Location

Central Study Contacts

ZiYu Li, MD，PhD

CONTACT

+86-010-88196605; ligregory369@hotmail.com

Xu Zhang, PhD

CONTACT

+86-13482323610; zhangx@geekgene.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)