GKL-006Allo Injection in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GKL-006Allo Injection.
- Who it may be relevant to
- Registry conditions: Solid Tumor Malignancies. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (12)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07704515 · GKL006ALLOST01