NCT05108077

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

September 22, 2021

Last Update Submit

January 12, 2022

Conditions

Bladder CancerRenal Cancer

Keywords

Bladder CancerRenal CancerCIK

Outcome Measures

Primary Outcomes (5)

  • The relapse-free survival

    The duration of relapse-free survival

    1 year

  • The relapse-free survival

    The duration of relapse-free survival

    2 year

  • The relapse-free survival

    The duration of relapse-free survival

    3 year

  • Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    1 month

  • Adverse effects associated with the therapy

    Determination of adverse effects associated with the therapy

    1 year

Study Arms (2)

Cytokine-induced killer cells

EXPERIMENTAL

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

Biological: cytokine-induced killer cellsOther: Standard treatment according to the Clinical protocols

Control

ACTIVE COMPARATOR

Patients with metastatic tumors of the urogenital area receiving standard treatment

Other: Standard treatment according to the Clinical protocols

Interventions

cytokine-induced killer cellsBIOLOGICAL

Autologous cytokine-induced killer cells injected intravenously

Cytokine-induced killer cells
Standard treatment according to the Clinical protocolsOTHER

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

ControlCytokine-induced killer cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsKidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesKidney Diseases

Study Officials

  • Andrei Hancharou

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

    STUDY DIRECTOR

  • Alexander Prokhorov, Dr

    Belarusian State Medical University

    STUDY DIRECTOR

Central Study Contacts

Andrei Hancharou, Dr

CONTACT

+375296248972hancharou@ibp.org.by

Oksana Timohina

CONTACT

+375299649741oksanabuschik@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

November 4, 2021

Study Start

March 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)