Rectal CancerPhase 1CEA+RC-BCGNCT02403505
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer
A Phase 1 study testing CEA protein antigen plus BCG Vaccine Mix for percutaneous use in people with Rectal Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.
Trial summary
Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients. 1. Treat CEA positive rectal cancer via Trained Immunity. 2. Read more about this study
- Who is it for?
- Ages 24 to 64 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- CEA protein antigen plus BCG Vaccine Mix for percutaneous use
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2021to 28 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 24 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical Rectal Cancer Diagnosis Stage 0 - IIA
- Clinical Rectal Cancer Diagnosis without symptoms
- Clinical Rectal Cancer Diagnosis without metastasis
- Positive testing CEA by blood-drawing
- TB negative participant is negative IGRA blood test with TB antigens.
Who cannot join
- Pregnant
- Thrombosis
- Allergy
- TB positive participant is positive IGRA blood test with TB antigens.
- Symptoms of rectal cancer
- Metastasis of rectal cancer
- Evidence of critical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701
Rockville, Maryland, 20853
About this study
Official title: Conducting an Early Phase Clinical Trial to Assess for CEA Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of CEA Positive Rectal Cancer Patients.
Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients.
- Treat CEA positive rectal cancer via Trained Immunity.
- Activate human CEA Protein Antigen Presentation Reaction.
- The human antigen presenting cells (APCs) can treat the CEA protein antigen into small peptide fragments, and then kill CEA positive rectal cancer cells in vivo.
Read the detailed description
- Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients
- 20 CEA Positive Rectal Cancer Patients
- Positive testing CEA by blood-drawing
- TB negative participant is negative IGRA blood test with TB antigens
- Clinical Rectal Cancer Diagnosis Stage 0 - IIA
- Clinical Rectal Cancer Diagnosis without symptoms
- Clinical Rectal Cancer Diagnosis without metastasis
- CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix
- By the percutaneous route with the multiple puncture device
- Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
- Our trial duration will be 12-week duration
- Conditions
- Rectal Cancer
- Being tested
- CEA protein antigen plus BCG Vaccine Mix for percutaneous use
- Keywords
- CEA, Antigen Presentation, APC, Trained Immunity, Innate Immune Memory, Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA protein antigen plus BCG Vaccine Mix for percutaneous useBiological
Also called CEA protein antigen plus BCG Organism Mix
- By the percutaneous route with the multiple puncture device
- CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix
| Study group | Role | What they receive |
|---|---|---|
| Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity | Experimental | CEA protein antigen 0.05 mg add into BCG Organism 50 MG Receives: Biological: CEA protein antigen plus BCG Vaccine Mix for percutaneous use |
What is being measured
The primary outcome is the main question the study is designed to answer.
20 Rectal Cancer Participants with CEA blood test
Positive testing CEA by blood-drawing
Measured: Duration up to 90 days
20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen
Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
Measured: Duration up to 90 days
20 Rectal Cancer Participants with IGRA blood test with TB antigens
- Negative IGRA blood test with TB antigens before percutaneous use
- Positive IGRA blood test with TB antigens after percutaneous use 21 days
Measured: Duration up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start28 Dec 2021
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * Single Usage * Single Dosage
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UnitedHealthcare
- Responsible party
- Sponsor-investigator, Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc
- Investigators
- HAN XU, MD/PhD/FAPCR, Study chair, IRB00009424--NPI-1831468511HAN XU, MD/PhD/FAPCR, Study director, IORG0007849--NPI-1023387701HAN XU, MD/PhD/FAPCR, Principal investigator, IORG0007849--FWA00015357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403505
- Sponsor's protocol ID
- IND 009549
- Other IDs
- FWA00015357, IORG0007849, IRB00009424, NPI-1831468511, NPI-1023387701, IND 009549
- Acronym
- CEA+RC-BCG
- Status last verified
- May 2026
- First submitted
- 15 Mar 2015
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conducting an Early Phase Clinical Trial to Assess for CEA Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of CEA Positive Rectal Cancer Patients.
- ClinicalTrials.gov ID
- NCT02403505
- Acronym / sponsor ID
- CEA+RC-BCG / IND 009549
- Conditions
- Rectal Cancer
- Keywords
- CEA, Antigen Presentation, APC, Trained Immunity, Innate Immune Memory, Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairIndustry (pharma, biotech, devices)
- Collaborators
- UnitedHealthcare
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- 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.
Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients.
- Treat CEA positive rectal cancer via Trained Immunity.
- Activate human CEA Protein Antigen Presentation Reaction.
- The human antigen presenting cells (APCs) can treat the CEA protein antigen into small peptide fragments, and then kill CEA positive rectal cancer cells in vivo.
Detailed description
- Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients
- 20 CEA Positive Rectal Cancer Patients
- Positive testing CEA by blood-drawing
- TB negative participant is negative IGRA blood test with TB antigens
- Clinical Rectal Cancer Diagnosis Stage 0 - IIA
- Clinical Rectal Cancer Diagnosis without symptoms
- Clinical Rectal Cancer Diagnosis without metastasis
- CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix
- By the percutaneous route with the multiple puncture device
- Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
- Our trial duration will be 12-week duration
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Single Usage * Single Dosage
| Arm | Type | Receives |
|---|---|---|
| Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity | Experimental | Biological: CEA protein antigen plus BCG Vaccine Mix for percutaneous useCEA protein antigen 0.05 mg add into BCG Organism 50 MG |
Who may qualify
- Ages
- 24 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical Rectal Cancer Diagnosis Stage 0 - IIA
- Clinical Rectal Cancer Diagnosis without symptoms
- Clinical Rectal Cancer Diagnosis without metastasis
- Positive testing CEA by blood-drawing
- TB negative participant is negative IGRA blood test with TB antigens.
Key exclusion criteria (7 listed)
- Pregnant
- Thrombosis
- Allergy
- TB positive participant is positive IGRA blood test with TB antigens.
- Symptoms of rectal cancer
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 |
|---|---|---|
| CEA protein antigen plus BCG Vaccine Mix for percutaneous useAlso: CEA protein antigen plus BCG Organism Mix* By the percutaneous route with the multiple puncture device * CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix | Biological | Assess for CEA Antigen Presentation Therapeutic Biological Product Mix activity |
Primary outcome
20 Rectal Cancer Participants with CEA blood test
Time frame: Duration up to 90 days
Positive testing CEA by blood-drawing
20 Rectal Cancer Participants with IGRA blood test with CEA protein antigen
Time frame: Duration up to 90 days
Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
20 Rectal Cancer Participants with IGRA blood test with TB antigens
Time frame: Duration up to 90 days
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- IORG0007849Link provided by the sponsor.
- IRB00009424Link provided by the sponsor.
- FWA00015357Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
HAN XU, MD/PhD/FAPCR study chair
IRB00009424--NPI-1831468511
HAN XU, MD/PhD/FAPCR study director
IORG0007849--NPI-1023387701
HAN XU, MD/PhD/FAPCR principal investigator
IORG0007849--FWA00015357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CEA protein antigen plus BCG Vaccine Mix for percutaneous use in people with Rectal Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
20 Rectal Cancer Participants with CEA blood test (time frame: Duration up to 90 days). 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?
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 28 May 2026.