Clinical trial · Interventional
GKL-006Allo Injection in Patients With Advanced Solid Tumors
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors
NCT07704515CI-TRIAL-00118035not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GKL-006Allo Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GKL-006Allo Injection
- description
- 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.
- interventionNames
- Biological: GKL-006Allo Injection
Primary outcomes (2)
- measure
- Number of Participants With Dose-Limiting Toxicities (DLTs)
- timeFrame
- From the first dose through the end of the DLT observation period, assessed up to 28 days.
- description
- Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria.
- measure
- Incidence and Severity of Adverse Events
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.