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New immune therapy aims to train body to attack rectal cancer cells

NCT ID NCT02403505

Disease control Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early phase trial tests a biological product mix designed to train the immune system to recognize and kill CEA-positive rectal cancer cells. The study involves 20 participants with early-stage rectal cancer (Stage 0 to IIA) who have not yet developed symptoms or metastasis. The goal is to see if the treatment can activate the body's antigen-presenting cells to destroy cancer cells.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of CEA positive rectal cancer patients. 20 CEA Positive Rectal Cancer Patients Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal carcinoma rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

Contacts and locations

Locations

  • Medicine Invention Design, Inc. (MIDI) - c/o - IORG0007849 - NPI-1023387701

    Rockville, Maryland, 20853, United States

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