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Gene-Engineered cells take on advanced cancer in early trial

NCT ID NCT00923806

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a gene therapy approach for metastatic cancer that produces a protein called CEA. Researchers took white blood cells from patients, added a gene to help them target CEA, and infused them back along with chemotherapy and a drug called IL-2. Only 3 people took part before the study was stopped, so results are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
genetically modified immune cells (anti-CEA TCR cells) and aldesleukin (IL-2)
What this could lead to
If successful, this approach could point toward a new treatment for metastatic cancers that express CEA.
What could go wrong
This was a very early, small trial that was terminated early. It is unclear if the treatment is safe or effective, and it may not work for most patients.

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

3 people

The number who actually took part.

Start date

Dec 2008

Finished

Nov 2011

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 years and older

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.

-INCLUSION CRITERIA: 1. Metastatic cancer that expresses carcinoembryonic antigen (CEA) as assessed by one of the following methods: * Immunohistochemistry of resected tissue, assessed by immunohistochemistry (IHC) in the Clinical Laboratory Improvement Amendments (CLIA) approved test in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH). Since the affinity of the antibody is weak, a result of greater than or equal to 1+ is considered positive. * Detection of elevated levels of circulating CEA using a standard clinical enzyme-linked immunosorbent (ELISA) assay. Results will be considered positive if CEA level is greater than 10 mcg/L. * Metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the NCI. 2. Hepatic metastases must represent the life limiting components of the disease defined as liver disease with a very high likelihood of causing the death of a patient according to the best clinical judgment of the attending physician. 3. Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred. 4. Greater than or equal to 18 years of age. 5. Willing to sign a durable power of attorney 6. Able to understand and sign the Informed Consent Document 7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Life expectancy of greater than three months. 9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen. 10. Patients must be human leukocyte antigen (HLA-A\*0201) positive 11. Serology: 1. Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) 2. Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative. 12. Hematology: 1. Absolute neutrophil count greater than 1000/mm\^3 without the support of filgrastim. 2. White blood cell (WBC) (greater than 3000/mm\^3. 3. Platelet count greater than 100,000/mm\^3. 4. Hemoglobin greater than 8.0 g/dl. 13. Chemistry: 1. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 2.5 times the upper limit of normal. 2. Serum creatinine less than or equal to 1.6 mg/dl. 3. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). EXCLUSION CRITERIA: 1. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 2. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. 3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 4. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 5. Concurrent systemic steroid therapy 6. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 7. History of coronary revascularization or ischemic symptoms 8. Any patient known to have an left ventricular ejection fraction (LVEF) less than or equal to 45%. 9. Documented LVEF of less than or equal to 45% tested in patients with: 1. History of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block 2. Age greater than or equal to 60 years old 10. Documented forced expiratory volume (FEV1) less than or equal to 60% predicted tested in patients with: 1. A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years). 2. Symptoms of respiratory dysfunction

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892, United States

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Other studies related to the condition(s) this trial covers.