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NCT Number: NCT07704515

GKL-006Allo Injection in Patients With Advanced 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.

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Key information

Conditions

Solid Tumor Malignancies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location contact

GCP Center

CONTACT

[email protected]

0316-5916013

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GKL-006Allo Injection

Biological

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

Primary outcomes

  1. Number of Participants With Dose-Limiting Toxicities (DLTs)

    Time frame: From the first dose through the end of the DLT observation period, assessed up to 28 days.

    Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria.

  2. Incidence and Severity of Adverse Events

    Time frame: 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.

    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.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: From the first dose of study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 18 months.

    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.

  2. Overall Survival (OS)

    Time frame: From the first dose of study treatment until death from any cause, assessed up to 18 months.

    Overall survival is defined as the time from the first dose of study treatment to death from any cause.

  3. Change From Baseline in EORTC QLQ-C30 Scale Scores

    Time frame: Baseline and scheduled post-baseline assessments, up to 18 months.

    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.

  4. Immunogenicity

    Time frame: From baseline through protocol-specified immunogenicity sampling time points, assessed up to 180 days.

    GKL-006 Alloantibodies (ADA) and their titers, anti-GKL-006 Allo neutralizing antibodies (Nab) and their titers, anti-HLA antibodies, etc. will be tested.

  5. Disease Control Rate (DCR)

    Time frame: From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.

    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.

  6. Objective Response Rate (ORR)

    Time frame: From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.

    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.

  7. Pharmacokinetic characterization of maximum observed plasma concentration (Cmax)

    Time frame: From 60 minutes before the first dose through 150 days.

    Maximum observed plasma concentration of GKL-006 following intravenous administration according to protocol.

  8. Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax)

    Time frame: From 60 minutes before the first dose through 150 days.

    Time to reach the maximum observed plasma concentration of GKL-006 following intravenous administration.

  9. Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC)

    Time frame: From 60 minutes before the first dose through 150 days.

    Area under the plasma concentration-time curve of GKL-006 following intravenous administration.

  10. Pharmacokinetic characterization of terminal elimination half-life (t½)

    Time frame: From 60 minutes before the first dose through 150 days.

    Terminal elimination half-life of GKL-006 calculated from plasma concentration-time data following intravenous administration.

  11. Pharmacodynamic Biomarkers of NK cells

    Time frame: From 60 minutes before the first dose through 150 days.

    Immune cell subsets

  12. Pharmacodynamic Biomarkers of Peripheral blood TNF-α

    Time frame: From 60 minutes before the first dose through 150 days.

    Immune-related cytokines

  13. Pharmacodynamic Biomarkers of Peripheral blood IFN-γ

    Time frame: From 60 minutes before the first dose through 150 days.

    Immune-related cytokines

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Hospital Chinese Academy of Medical Sciences

CONTACT

[email protected]

+86-316-5916013

Sponsors and collaborators

Lead sponsor

Beijing Gene Key Life Technology Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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