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NCT06991478

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

Not yet recruiting Phase 1, PHASE2 Last updated 28 May 2025
What this trial tests

Phase 1, PHASE2 trial testing SK-NK injection in Solid Tumor, Malignant Ascites in 10 participants. Not yet recruiting.

Timeline
30 May 2025
Primary endpoint
30 May 2026
30 July 2026

Quick facts

Lead sponsorTianjin Medical University Cancer Institute and Hospital
PhasePhase 1, PHASE2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date30 May 2025
Primary completion30 May 2026
Estimated completion30 July 2026

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 75, any sex, with Solid Tumor, Malignant Ascites. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06991478.

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