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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GKL-006Allo Injection | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Contact | +86-316-5916013 | lining@cisams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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Participants will be assigned to sequential study stages, including a single-dose escalation stage, a multiple-dose treatment stage, and, if conducted, dose-expansion stages according to protocol-specified safety review and dose-escalation rules.
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This is an open-label study. Participants, investigators, and study personnel will be aware of the treatment administered.
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| 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. |