Colon CancerNCT04994093
Creating an Innovative AI-based Technology TCRact for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies
An observational study of Colon Cancer and Cancer, run by Ardigen at 1 site in Poland.
Trial summary
The PROJECT OBJECTIVE is to create an innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY for the design and optimization of T-cell receptors (TCRs) capable of recognizing specific tumor antigens presented on Human Leukocyte Antigen (HLA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Cancer
- What is being tested?
- Collection of blood (PBMC), biopsy (FFPE) and stool samples.
- How many people
- 118 participants
- Where
- 1 sitePoland
- Study dates
- 6 Oct 2021to 28 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving routine treatment.
Who may be able to join
- Clinical diagnosis of advanced resectable colorectal cancer (Active stage II, III or IV)
- Histopathologically confirmed as adenocarcinoma
- Age 18 or over
- Being able to understand and sign the Informed Consent Form (ICF)
- Qualification for resection within 3 months from W0 or condition after primary tumor resection, not longer than 5 years from surgery
Who cannot join
- Mucinous colorectal adenocarcinoma
- Canal and anal edge cancer,
- Adenocarcinoma of the appendix,
- Patients treated with neoadjuvant therapy or radiation therapy in the 3 months prior to study enrollment.
- Patients treated with systemic chemotherapy in the 3 months prior to study enrollment.
- Histopathological diagnosis other than adenocarcinoma
Show all 12Show fewer
- Remission
- History of inflammatory bowel diseases
- Pregnancy
- HIV infection
- Active infection with hepatitis B and C viruses
- Leukocytopenia
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie National Research Institute of Oncology
Krakow
About this study
Official title: Creating an Innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY TCRact to Launch a NEW SERVICE for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies
The PROJECT OBJECTIVE is to create an innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY for the design and optimization of T-cell receptors (TCRs) capable of recognizing specific tumor antigens presented on Human Leukocyte Antigen (HLA). The technology will be based on bioinformatics (including molecular modelling) and artificial intelligence (including predictive, generative and optimization models). PROJECT TASKS are dedicated to the implementation of individual technological components (including the database necessary for their preparation) and to performing IN VITRO evaluation rounds to optimize the technology.
Integration, within an IN SILICO TECHNOLOGY, of processes which currently require huge amounts of in vitro laboratory experiments that are necessary for bringing new TCR-based cancer immunotherapies into clinical trials:
- finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
- testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
- optimization of pHLA:TCR binding affinity and toxicity.
- Conditions
- Colon Cancer, Cancer
- Being tested
- Collection of blood (PBMC), biopsy (FFPE) and stool samples.
- Keywords
- Immunology, TCR, FFPE, PBMC, Colon Cancer, Immuno-Oncology, Cancer, Oncology
- Medical subject headings
- Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood (PBMC), biopsy (FFPE) and stool samples.Other
Patients receiving routine treatment financed by the Polish National Health Fund (NFZ).
| Study group | Role | What they receive |
|---|---|---|
| COLON CANCER | This cohort will consist of 100 patients with Colon Cancer. Receives: Other: Collection of blood (PBMC), biopsy (FFPE) and stool samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
Measured: Inclusion
Testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
Measured: Inclusion
Optimization of pHLA:TCR binding affinity and toxicity
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start6 Oct 2021
- Primary completion5 Dec 2022
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardigen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994093
- Sponsor's protocol ID
- TCRact
- Other IDs
- POIR.01.01.01-00-0019/20
- Status last verified
- Jun 2024
- First submitted
- 29 Jul 2021
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bujak J, Klek S, Balawejder M, Kociniak A, Wilkus K, Szatanek R, Orzeszko Z, Welanyk J, Torbicz G, Jeckowski M, Kucharczyk T, Wohadlo L, Borys M, Stadnik H, Wysocki M, Kayser M, Slomka ME, Kosmowska A, Horbacka K, Gach T, Markowska B, Kowalczyk T, Karon J, Karczewski M, Szura M, Sanecka-Duin A, Blum A. Creating an Innovative Artificial Intelligence-Based Technology (TCRact) for Designing and Optimizing T Cell Receptors for Use in Cancer Immunotherapies: Protocol for an Observational Trial. JMIR Res Protoc. 2023 Jul 13;12:e45872. doi: 10.2196/45872.
PubMed 37440307
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating an Innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY TCRact to Launch a NEW SERVICE for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies
- ClinicalTrials.gov ID
- NCT04994093
- Acronym / sponsor ID
- TCRact
- Conditions
- Colon Cancer, Cancer
- Keywords
- Immunology, TCR, FFPE, PBMC, Colon Cancer, Immuno-Oncology, Cancer, Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- ArdigenIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 6 Aug 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.
The PROJECT OBJECTIVE is to create an innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY for the design and optimization of T-cell receptors (TCRs) capable of recognizing specific tumor antigens presented on Human Leukocyte Antigen (HLA). The technology will be based on bioinformatics (including molecular modelling) and artificial intelligence (including predictive, generative and optimization models). PROJECT TASKS are dedicated to the implementation of individual technological components (including the database necessary for their preparation) and to performing IN VITRO evaluation rounds to optimize the technology.
Integration, within an IN SILICO TECHNOLOGY, of processes which currently require huge amounts of in vitro laboratory experiments that are necessary for bringing new TCR-based cancer immunotherapies into clinical trials:
- finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
- testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
- optimization of pHLA:TCR binding affinity and toxicity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COLON CANCER | – | Other: Collection of blood (PBMC), biopsy (FFPE) and stool samples.This cohort will consist of 100 patients with Colon Cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving routine treatment.
Key inclusion criteria (5 listed)
- Clinical diagnosis of advanced resectable colorectal cancer (Active stage II, III or IV)
- Histopathologically confirmed as adenocarcinoma
- Age 18 or over
- Being able to understand and sign the Informed Consent Form (ICF)
- Qualification for resection within 3 months from W0 or condition after primary tumor resection, not longer than 5 years from surgery
Key exclusion criteria (12 listed)
- Mucinous colorectal adenocarcinoma
- Canal and anal edge cancer,
- Adenocarcinoma of the appendix,
- Patients treated with neoadjuvant therapy or radiation therapy in the 3 months prior to study enrollment.
- Patients treated with systemic chemotherapy in the 3 months prior to study enrollment.
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 |
|---|---|---|
| Collection of blood (PBMC), biopsy (FFPE) and stool samples.Patients receiving routine treatment financed by the Polish National Health Fund (NFZ). | Other | COLON CANCER |
Primary outcome
Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
Time frame: Inclusion
Testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
Time frame: Inclusion
Optimization of pHLA:TCR binding affinity and toxicity
Time frame: Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 37440307Bujak J, Klek S, Balawejder M, Kociniak A, Wilkus K, Szatanek R, Orzeszko Z, Welanyk J, Torbicz G, Jeckowski M, Kucharczyk T, Wohadlo L, Borys M, Stadnik H, Wysocki M, Kayser M, Slomka ME, Kosmowska A, Horbacka K, Gach T, Markowska B, Kowalczyk T, Karon J, Karczewski M, Szura M, Sanecka-Duin A, Blum A. Creating an Innovative Artificial Intelligence-Based Technology (TCRact) for Designing and Optimizing T Cell Receptors for Use in Cancer Immunotherapies: Protocol for an Observational Trial. JMIR Res Protoc. 2023 Jul 13;12:e45872. doi: 10.2196/45872.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Cancer, run by Ardigen at 1 site in Poland.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 26 Jun 2024. 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA) (time frame: Inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994093, which also lists 1 linked publication.
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 26 Jun 2024.