Solid Tumor MalignanciesPhase 1NCT07704515
GKL-006Allo Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing GKL-006Allo Injection in people with Solid Tumor Malignancies, run by Beijing Gene Key Life Technology Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- GKL-006Allo Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 31 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
GCP Center, 0316-5916013, lining@cisams.ac.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor Malignancies
- Being tested
- GKL-006Allo Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKL-006Allo InjectionBiological
Also called Allogeneic iNKT Cell Therapy, Allogeneic invariant natural killer T cell therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: GKL-006Allo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs)
Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria.
Measured: 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.
Measured: 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 outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of NK cells
Immune cell subsets
Measured: From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of Peripheral blood TNF-α
Immune-related cytokines
Measured: From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of Peripheral blood IFN-γ
Immune-related cytokines
Measured: From 60 minutes before the first dose through 150 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ning Li, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704515
- Sponsor's protocol ID
- GKL006ALLOST01
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07704515
- Acronym / sponsor ID
- GKL006ALLOST01
- Conditions
- Solid Tumor Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Beijing Gene Key Life Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GKL-006Allo Injection | Experimental | Biological: GKL-006Allo InjectionNatural 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GKL-006Allo InjectionAlso: Allogeneic iNKT Cell Therapy, Allogeneic invariant natural killer T cell therapyGKL-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. | Biological | GKL-006Allo Injection |
Primary outcome
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.
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.
13 secondary outcomes
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.
Overall Survival (OS)
Time frame: 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
Time frame: Baseline and scheduled post-baseline assessments, up to 18 months.
Immunogenicity
Time frame: From baseline through protocol-specified immunogenicity sampling time points, assessed up to 180 days.
Disease Control Rate (DCR)
Time frame: From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.
Pharmacokinetic characterization of maximum observed plasma concentration (Cmax)
Time frame: From 60 minutes before the first dose through 150 days.
Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax)
Time frame: From 60 minutes before the first dose through 150 days.
Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC)
Time frame: From 60 minutes before the first dose through 150 days.
Pharmacokinetic characterization of terminal elimination half-life (t½)
Time frame: From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of NK cells
Time frame: From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of Peripheral blood TNF-α
Time frame: From 60 minutes before the first dose through 150 days.
Pharmacodynamic Biomarkers of Peripheral blood IFN-γ
Time frame: From 60 minutes before the first dose through 150 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Li, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GKL-006Allo Injection in people with Solid Tumor Malignancies, run by Beijing Gene Key Life Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Hospital Chinese Academy of Medical Sciences (+86-316-5916013, lining@cisams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 3 Nov 2026.