Clinical trial · Interventional
A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant. This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IL-12
- description
- A single dose of IL-12, given intravenously.
- interventionNames
- Biological: IL-12
Primary outcomes (1)
- measure
- Number of side effects by type and severity
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Levels of IL-12
- timeFrame
- Day 28 to 2 years
- description
- For patients who still show evidence of IL-12 producing AML cells on day 28, will be seen weekly for up to 2 years until there is no evidence of IL-12 producing cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available