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Engineered t cells with a kill switch aim to make stem cell transplants safer

NCT ID NCT00710892

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new approach for people receiving a stem cell transplant from a partially matched family donor. The donor's immune cells (T cells) are modified in the lab to include a 'suicide gene' that can be activated by a drug if the cells attack the patient's body, causing graft-versus-host disease (GvHD). The goal is to see if higher doses of these modified T cells can help the immune system recover faster while keeping GvHD under control. The trial involves 10 patients with blood cancers or related disorders.

What this could mean

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

Active substance
allodepleted T cells with inducible caspase 9 suicide gene
What this could lead to
If it works, this could allow safer use of partially matched donor stem cells by giving doctors a way to turn off immune cells that attack the patient's body.
What could go wrong
This is a very early phase 1 trial with only 10 participants. The suicide switch has not been proven to work in humans, and patients who develop graft-versus-host disease will still need standard treatments.

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

10 people

The number who actually took part.

Start date

Dec 2008

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 65 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.

INCLUSION CRITERIA: At the time of transplant: A. Patients (up to 65 years of age) with: 1. ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease. 2. Myelodysplastic syndrome. 3. AML after first relapse or with primary refractory disease. 4. CML 5. Hemophagocytic lymphohistiocytosis (HLH); familial hemophagocytic lymphohistiocytosis (FLH); viral-associated hemophagocytic syndrome (VAHS); patients with severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T or NK cell malignancy; X-linked lymphoproliferative disease (XLP) B. Lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor. At the time of allodepleted T cell infusion: 1. Engrafted with ANC greater than 500. 2. Must have greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease. 3. Life expectancy greater than 30 days 4. Lansky/Karnofsky scores greater than or equal to 60 5. Absence of severe renal disease (creatinine greater than 2X normal for age) 6. Absence of severe hepatic disease (direct bilirubin greater than 2 mg/dL, or SGOT greater than 200 7. Oxygen saturation greater than 94% on room air 8. Patient/Guardian able to give informed consent EXCLUSION CRITERIA: At the time of transplant: 1\. Pregnancy\* At the time of allodepleted T cell infusion: 1. GvHD 2. Severe intercurrent infection 3. Pregnancy\* 4. Other investigational drugs in the prior 30 days * Pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.

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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

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Methodist Hospital

    Houston, Texas, 77030, United States

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