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SK-NK Injection in Patients With Advanced Solid Tumors Accompanied by Malignant Ascites

NCT06991478 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-28

No results posted yet for this study

Summary

This study is divided into two phases. Patients with recurrent or metastatic solid tumors accompanied by malignant ascites who have failed previous standard treatments are enrolled. The first phase is a single-arm, open-dose exploratory Phase I clinical study. In this phase, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection. Once a week for 6 consecutive infusions. After completing 6 consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive 6 consecutive infusions of SK-NK injection. After completing 12 infusions, whether to continue the treatment subsequently could be determined based on the patient's condition. The second stage will be based on the results of the first stage to further verify the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D, etc.

Conditions

  • Solid Tumor, Malignant Ascites

Interventions

DRUG

SK-NK injection

In this stage, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection once a week for six consecutive times. After completing six consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive six consecutive infusions of SK-NK injection. After completing twelve infusions, the decision on whether to continue the treatment subsequently could be made based on the patient's condition

DRUG

SK-NK injection

Based on the dose selected from the results of the first stage, the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D were further verified. The types of cancer and the number of cases enrolled in stage II are to be determined

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2026-05-30
Completion
2026-07-30

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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 NCT06991478 on ClinicalTrials.gov