Scientists reprogram leukemia cells to fight themselves
NCT ID NCT02483312
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new approach for people with acute myeloid leukemia (AML) that has returned or is likely to return, and who cannot have a bone marrow transplant. Researchers take a patient's own leukemia cells, modify them in the lab to produce a protein called IL-12, and then give them back. The goal is to see if this treatment is safe and can help control the disease.
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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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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Sep 2015
- Expected to finish
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Aug 2026
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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18 years and older
- 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: * Patient with AML and \>=18 years of age. * Agrees to participate in the study and signs the informed consent * Viable cells are available for successful modification * First or higher complete remission and have high risk features of relapse. * Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment. * Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment. * Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results. * Agree to use contraception * Not pregnant * Able to comply with study procedures Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \>2 * Known persistent infection * Known central nervous system (CNS) disease * Greater than 10% blasts in the bone marrow or circulating blast cells * Life expectancy \< 2 months * Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine. * Patients who are HIV positive.
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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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Princess Margaret Centre Centre
Toronto, Ontario, M5G 2M9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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