Suicide Gene-Equipped t cells aim to make stem cell transplants safer
NCT ID NCT01494103
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial tests whether specially modified T cells from a partially matched donor can help patients recover their immune system faster after a stem cell transplant. The T cells are engineered with a 'suicide gene' that allows doctors to destroy them if they cause graft-versus-host disease (GvHD), a serious complication. The study enrolls people with blood cancers or immune disorders who lack a perfectly matched donor. The goal is to find a safe dose of these cells and see if they improve immune recovery without causing severe GvHD.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iCaspase9-transduced T cells and AP1903
- What this could lead to
- If it works, this approach could help patients recover their immune system faster after a stem cell transplant while providing a safety switch to stop dangerous graft-versus-host disease.
- What could go wrong
- This is an early-phase trial with only 15 participants, so results may not apply broadly. The suicide gene may not activate fully, or the modified cells could cause unexpected side effects.
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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15 people
The number who actually took part.
- Start date
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Nov 2011
- Expected to finish
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May 2029
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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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.
Show the full entry requirements Hide 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: Inclusion Criteria at Time of Procurement: 1. Lack of a 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. 2. High risk disease in one of the following: * Myelodysplastic syndrome (MDS) in one of the following categories: RCMD with an IPSS-R of intermediate, poor, or very poor, RAEB-1, or RAEB-2 * Acute myeloid leukemia (AML) after first relapse or primary refractory disease * Chronic myelogenous leukemia (CML) in Chronic Phase 2 or greater, Accelerated Phase or Blast Crisis * Acute lymphoblastic leukemia (ALL) after first relapse or primary refractory disease, or High-Grade Non Hodgkin lymphoma (NHL) Stage III or IV after first relapse or primary refractory disease * Hemophagocytic lymphohistiocytosis (HLH) * Familial hemophagocytic lymphohistiocytosis (FLH) * Viral-associated hemophagocytic syndrome (VAHS) * T or NK cell lymphoproliferative syndrome * X-linked lymphoproliferative disease (XLP) Inclusion Criteria at Time of T Cell Infusion: 1. Engrafted with an absolute neutrophil count (ANC) \> 500 cells/µL 2. Greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease 3. Life expectancy \> 30 days 4. Lansky/Karnofsky score greater than or equal to 60 5. Absence of severe renal disease (creatinine \> 2X upper limit of normal for age) 6. Absence of severe hepatic disease (direct bilirubin \> 3X upper limit of normal or SGOT \> 3X upper limit of normal) 7. Oxygen saturation \> 94% on room air 8. Patient/Guardian able to give informed consent 9. AP1903 available in sufficient quantities to allow for treatment of the patient Exclusion Criteria: Exclusion Criteria at Time of 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
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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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Other studies related to the condition(s) this trial covers.
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