GKL-006Allo Injection in Patients With Advanced Solid Tumors

NCT07704515 | Not Yet Recruiting Phase 1

• 1 other identifier: GKL006ALLOST01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (13)

• Progression-Free Survival (PFS)

  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)

  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

  Baseline and scheduled post-baseline assessments, up to 18 months.

• Immunogenicity

  From baseline through protocol-specified immunogenicity sampling time points, assessed up to 180 days.

• Disease Control Rate (DCR)

  From the first dose of study treatment through scheduled tumor assessments, assessed up to 18 months.

Study Arms (1)

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.

Biological: GKL-006Allo Injection

Interventions

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.

Also known as: Allogeneic iNKT Cell Therapy, Allogeneic invariant natural killer T cell therapy

GKL-006Allo Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Gene Key Life Technology Co., Ltd: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Officials

• Ning Li, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Hospital Chinese Academy of Medical Sciences

CONTACT

+86-316-5916013; lining@cisams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. Participants, investigators, and study personnel will be aware of the treatment administered.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)