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NOT YET RECRUITING
NCT07784777
PHASE1

NK Cell Injection for Advanced Solid Tumors

Sponsor: BOE Technology Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, single-arm, dose-escalation Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of NK Cell Injection in patients with advanced solid tumors. Eligible participants who have signed written informed consent will be screened and, if qualified, assigned a enrollment number and sequentially assigned to the designated dose group. The study employs a traditional "3+3" dose-escalation design. Each dose group enrolls at least 3 participants, with each participant receiving only one corresponding dose level, until the MTD or RP2D is determined. The study consists of four periods: Screening Period, Treatment Period (including lymphodepleting chemotherapy), Safety Follow-up Period, and Survival Follow-up Period.

Official title: An Open-Label, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of NK Cell Injection in the Treatment of Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-09

Completion Date

2028-09

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

NK CELLS

Allogeneic natural killer (NK) cell therapy (non-genetically modified)