Bladder CancerPhase 1/2NCT05108077
Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells
A Phase 1/2 study testing cytokine-induced killer cells and Standard treatment according to the Clinical protocols in people with Bladder Cancer and Renal Cancer, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer, Renal Cancer
- What is being tested?
- cytokine-induced killer cells and Standard treatment according to the Clinical protocols
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Mar 2022to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- any medical condition which can be associated with the high risk for the patient;
- pregnancy/lactation;
- chronic infections, including hepatitis B/C, tuberculosis, HIV
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: Treatment of Metastatic Tumors of the Urogenital Area (Bladder Cancer, Renal Cancel) With Cytokine-induced Killer Cells
Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells
Read the detailed description
Treatment of metastatic tumors of the urogenital area using autologous cytokine-induced killer cells
- Conditions
- Bladder Cancer, Renal Cancer
- Being tested
- cytokine-induced killer cells, Standard treatment according to the Clinical protocols
- Keywords
- Bladder Cancer, Renal Cancer, CIK
- Medical subject headings
- Urinary Bladder Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine-induced killer cellsBiological
Autologous cytokine-induced killer cells injected intravenously
Standard treatment according to the Clinical protocolsOther
Standard treatment of bladder/renal cancer according to the Clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| Cytokine-induced killer cells | Experimental | Patients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells Receives: Biological: cytokine-induced killer cells; Other: Standard treatment according to the Clinical protocols |
| Control | Active comparator | Patients with metastatic tumors of the urogenital area receiving standard treatment Receives: Other: Standard treatment according to the Clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relapse-free survival
The duration of relapse-free survival
Measured: 1 year
The relapse-free survival
The duration of relapse-free survival
Measured: 2 year
The relapse-free survival
The duration of relapse-free survival
Measured: 3 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Andrei Hancharou, Study director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusAlexander Prokhorov, Dr, Study director, Belarusian State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108077
- Sponsor's protocol ID
- IBCE_CIK
- Status last verified
- Jan 2022
- First submitted
- 22 Sep 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Metastatic Tumors of the Urogenital Area (Bladder Cancer, Renal Cancel) With Cytokine-induced Killer Cells
- ClinicalTrials.gov ID
- NCT05108077
- Acronym / sponsor ID
- IBCE_CIK
- Conditions
- Bladder Cancer, Renal Cancer
- Keywords
- Bladder Cancer, Renal Cancer, CIK
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytokine-induced killer cells | Experimental | Biological: cytokine-induced killer cells, Other: Standard treatment according to the Clinical protocolsPatients with the metastatic tumors of the urogenital area receiving standard treatment and autologous cytokine-induced killer cells |
| Control | Active comparator | Other: Standard treatment according to the Clinical protocolsPatients with metastatic tumors of the urogenital area receiving standard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- any medical condition which can be associated with the high risk for the patient;
- pregnancy/lactation;
- chronic infections, including hepatitis B/C, tuberculosis, HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytokine-induced killer cellsAutologous cytokine-induced killer cells injected intravenously | Biological | Cytokine-induced killer cells |
| Standard treatment according to the Clinical protocolsStandard treatment of bladder/renal cancer according to the Clinical protocols | Other | Control, Cytokine-induced killer cells |
Primary outcome
The relapse-free survival
Time frame: 1 year
The duration of relapse-free survival
The relapse-free survival
Time frame: 2 year
The duration of relapse-free survival
The relapse-free survival
Time frame: 3 year
The duration of relapse-free survival
Adverse effects associated with the therapy
Time frame: 1 month
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time frame: 1 year
Determination of adverse effects associated with the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
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A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
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Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Hancharou study director
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Alexander Prokhorov, Dr study director
Belarusian State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cytokine-induced killer cells and Standard treatment according to the Clinical protocols in people with Bladder Cancer and Renal Cancer, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrei Hancharou, Dr (+375296248972, hancharou@ibp.org.by), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relapse-free survival (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.