Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells

Phase 1

• Conditions: Bladder Cancer; Renal Cancer
• Interventions: Other: Standard treatment according to the Clinical protocols; Biological: cytokine-induced killer cells

• Registration Number: NCT05108077
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells

Detailed Description

Treatment of metastatic tumors of the urogenital area using autologous cytokine-induced killer cells

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-24
• Study First Posted: 2021-11-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-14
• Study Start: 2022-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Histologically confirmed diagnosis of pTa metastatic tumors of the urogenital area;
• Patient who require repetitive transurethral resection;
• Expression of muc-1/wt-1 by the tumor;
• EGOC 0-3;

Exclusion Criteria

• any medical condition which can be associated with the high risk for the patient;
• pregnancy/lactation;
• chronic infections, including hepatitis B/C, tuberculosis, HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard treatment according to the Clinical protocols	Patients with metastatic tumors of the urogenital area receiving standard treatment
Cytokine-induced killer cells	cytokine-induced killer cells	Patients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells
Cytokine-induced killer cells	Standard treatment according to the Clinical protocols	Patients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells

Primary Outcome Measures

Name	Time	Method
The relapse-free survival	3 year	The duration of relapse-free survival
Adverse effects associated with the therapy	1 year	Determination of adverse effects associated with the therapy

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus