GKL-006Allo Injection in Patients With Advanced Solid Tumors

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of GKL-006Allo Injection in participants with advanced solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor Malignancies
• Intervention / Treatment: Biological: GKL-006Allo Injection

Detailed Description

This Phase 1 study will evaluate GKL-006Allo Injection in participants with advanced or metastatic solid tumors who have failed or are intolerant to standard therapy.

The study includes single-dose and multiple-dose treatment, with a potential dose-expansion stage to further evaluate selected dose level according to protocol-specified criteria. The single-dose and multiple-dose stages are designed to characterize safety, tolerability, and biological activity across protocol-specified dose levels.

Participants will receive GKL-006Allo Injection according to the study protocol and will undergo scheduled safety monitoring, tumor assessments, pharmacokinetic and pharmacodynamic sampling, and immunogenicity testing during treatment and follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cancer Hospital Chinese Academy of Medical Sciences; Phone Number: +86-316-5916013; Email: lining@cisams.ac.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: GCP Center; Phone Number: 0316-5916013; Email: lining@cisams.ac.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Able to understand and voluntarily sign the informed consent form.
• Aged 18 to 75 years.
• Histologically, cytologically or clinical confirmed unresectable locally advanced or metastatic solid tumor that has failed standard therapy.
• At least one measurable tumor lesion during screening according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and life expectancy of at least 3 months.
• Adequate hematologic and organ function.
• Participants of childbearing potential must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after the end of study treatment.
• Able to communicate with the investigator, comply with study visits, and understand and follow study requirements.

Exclusion Criteria:

• Recently received radical radiotherapy or other anti-tumor therapy.
• Known hypersensitivity to any component of the study treatment.
• Prior history or concurrent malignancy that has not been cured.
• Active infection, known or suspected autoimmune disease.
• Last anti-tumor treatment toxicity not yet recovered to suitable status.
• Other organ dysfunction or situations deemed inappropriate by the investigator.

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: GKL-006Allo Injection; Natural killer T cells (NKT) are a type of special lymphocyte discovered in recent years that mediate both innate and adaptive immunity, and are considered the fourth type of lymphocyte. GKL-006Allo is an allogeneic iNKT cell.	Biological: GKL-006Allo Injection; GKL-006Allo Injection is an allogeneic invariant natural killer T (iNKT) cell therapy. It will be administered according to the dose level, dosing schedule, and treatment stage specified in the protocol.; Other Names: Allogeneic iNKT Cell Therapy; Allogeneic invariant natural killer T cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs)	Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria.	From the first dose through the end of the DLT observation period, assessed up to 28 days.
Incidence and Severity of Adverse Events	Safety will be assessed by the incidence and severity of adverse events, serious adverse events, laboratory abnormalities, electrocardiogram abnormalities, physical examination findings, and vital sign abnormalities.	From the first dose of study treatment until 28 days after the pointed dose of study treatment. The safety monitor will be continued until the end of the study, up to 18 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first, according to RECIST v1.1.	From the first dose of study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 18 months.
Overall Survival (OS)	Overall survival is defined as the time from the first dose of study treatment to death from any cause.	From the first dose of study treatment until death from any cause, assessed up to 18 months.
Change From Baseline in EORTC QLQ-C30 Scale Scores	Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores for each scale range from 0 to 100. Higher scores on the functional scales and global health status/quality-of-life scale indicate better functioning or quality of life.	Baseline and scheduled post-baseline assessments, up to 18 months.
Immunogenicity	GKL-006 Alloantibodies (ADA) and their titers, anti-GKL-006 Allo neutralizing antibodies (Nab) and their titers, anti-HLA antibodies, etc. will be tested.	From baseline through protocol-specified immunogenicity sampling time points, assessed up to 180 days.
Disease Control Rate (DCR)	Disease control rate is defined as the proportion of participants with a best overall response of complete response, partial response, or stable disease according to RECIST v1.1.	From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.
Objective Response Rate (ORR)	Objective response rate is defined as the proportion of participants with a best overall response of complete response or partial response according to RECIST v1.1.	From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.
Pharmacokinetic characterization of maximum observed plasma concentration (Cmax)	Maximum observed plasma concentration of GKL-006 following intravenous administration according to protocol.	From 60 minutes before the first dose through 150 days.
Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax)	Time to reach the maximum observed plasma concentration of GKL-006 following intravenous administration.	From 60 minutes before the first dose through 150 days.
Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC)	Area under the plasma concentration-time curve of GKL-006 following intravenous administration.	From 60 minutes before the first dose through 150 days.
Pharmacokinetic characterization of terminal elimination half-life (t½)	Terminal elimination half-life of GKL-006 calculated from plasma concentration-time data following intravenous administration.	From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of NK cells	Immune cell subsets	From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of Peripheral blood TNF-α	Immune-related cytokines	From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of Peripheral blood IFN-γ	Immune-related cytokines	From 60 minutes before the first dose through 150 days.

Collaborators and Investigators

• Sponsor: Beijing Gene Key Life Technology Co., Ltd
• Investigators: Principal Investigator: Ning Li, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GKL006ALLOST01

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