NK Cell Injection for Advanced Solid Tumors

Sponsor
BOE Technology Group Co., Ltd.
Study ID
NCT07784777
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NK CELLS — BIOLOGICAL
    Allogeneic natural killer (NK) cell therapy (non-genetically modified)

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-escalation Phase I clinical study
    Group 1: 2 x 10\^9 cells/dose Group 2: 4 x 10\^9 cells/dose Group 3: 8 x 10\^9 cells/dose Optional higher dose group: 1 x 10\^10 cells/dose (if safety is well-tolerated within the 2-8 x 10\^9 cells/dose range, upon SRC assessment after completion of the 8 x 10\^9 cells/dose DLT observation period). Each dose group must include at least 1 female participant.

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: Up to 21 days post first infusion ]

Central Contacts

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