Engineered t cells with a kill switch aim to make stem cell transplants safer
NCT ID NCT00710892
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Start date
-
Dec 2008
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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The Methodist Hospital
Houston, Texas, 77030, United States
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