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

NCT ID: NCT05108077

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Bladder Cancer Renal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cytokine-induced killer cells

Patients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells

Group Type EXPERIMENTAL

cytokine-induced killer cells

Intervention Type BIOLOGICAL

Autologous cytokine-induced killer cells injected intravenously

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Standard treatment of bladder/renal cancer according to the Clinical protocols

Control

Patients with metastatic tumors of the urogenital area receiving standard treatment

Group Type ACTIVE_COMPARATOR

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Standard treatment of bladder/renal cancer according to the Clinical protocols

Interventions

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cytokine-induced killer cells

Autologous cytokine-induced killer cells injected intravenously

Intervention Type BIOLOGICAL

Standard treatment according to the Clinical protocols

Standard treatment of bladder/renal cancer according to the Clinical protocols

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrei Hancharou

Role: STUDY_DIRECTOR

the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Alexander Prokhorov, Dr

Role: STUDY_DIRECTOR

Belarusian State Medical University

Locations

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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, , Belarus

Site Status

Countries

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Belarus

Central Contacts

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Andrei Hancharou, Dr

Role: CONTACT

+375296248972

Oksana Timohina

Role: CONTACT

+375299649741

Other Identifiers

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IBCE_CIK

Identifier Type: -

Identifier Source: org_study_id

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