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NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors

NCT07561437 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-01

No results posted yet for this study

Summary

Study Population: Adult subjects aged 18-75 years with relapsed/refractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy.

Study Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each):

Group A (Intravenous infusion): For subjects with small-volume malignant ascites.

Group B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites.

Each group will follow a conventional "3+3" dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles.

Primary Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally.

Secondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).

Conditions

Interventions

BIOLOGICAL

NK521 Cell Injection

Gene-edited natural killer (NK) cell product with knockout of TIGIT, NKG2A, and TGF-β, administered via intravenous infusion or intraperitoneal perfusion for the treatment of malignant ascites associated with advanced solid tumors.

Sponsors & Collaborators

  • Base Therapeutics (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2028-04-30
Completion
2028-10-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07561437 on ClinicalTrials.gov