Clinical Trials in China / NCT07704515
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Phase 1
GKL-006Allo Injection in Patients With Advanced Solid Tumors
NCT07704515 · tracked via the Priya Life Science China tracker
Condition(s) studied
Solid Tumor Malignancies
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Number of Participants With Dose-Limiting Toxicities (DLTs) — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07704515 on ClinicalTrials.gov ↗ ← All trials in China