New shot could help kids with tough leukemia
NCT ID NCT07134088
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a subcutaneous (under the skin) injection of blinatumomab in children under 12 with relapsed/refractory or minimal residual disease positive B-cell acute lymphoblastic leukemia. The goal is to see if this easier-to-give form is safe and effective at achieving remission. About 104 children will participate across two phases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- blinatumomab (a drug that helps the immune system attack cancer cells)
- What this could lead to
- If successful, this could offer a more convenient, less invasive treatment option for children with hard-to-treat B-cell acute lymphoblastic leukemia, potentially improving remission rates.
- What could go wrong
- This is an early-phase trial (1b/2) with a small number of participants, so results may not apply broadly. Side effects from blinatumomab can be serious, including neurological problems and cytokine release syndrome.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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28 to 4383 days
- Sex
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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 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: * Age ≥28 days to \<12 years at the time of informed consent/assent. * Lansky Performance Status (LPS) of ≥ 50%. * For Phase 1b and Phase 2 cohort in participants with R/R B-ALL: * Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic hematopoietic stem cell transplant (HSCT). * Greater than or equal to 5% blasts in the bone marrow (BM) is considered as relapse in the BM. * For Phase 2 cohort in participants with MRD+ B-ALL: * Participants with MRD+ B-ALL must have between ≥ 0.1% and \< 5% blasts in the BM. * Prior CD19-directed therapy will be allowed (with demonstrated continued CD19+ expression) if treatment ended \>4 weeks prior to start of protocol therapy and no prior central nervous system (CNS) complications. * Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible. Exclusion Criteria: * Active ALL in the CNS. * History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or severe (≥ grade 3) CNS events including immune effector cell-associated neurologic syndrome (ICANS) from prior CAR-T or other T-cell engager therapies. * Isolated EM disease. * Current autoimmune disease or history of autoimmune disease with potential CNS involvement. * Patients with Down Syndrome are not eligible for this study. * Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication. * Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus. * Presence of an acute or uncontrolled chronic infection, or any other concurrent disease or medical condition that could be worsened by the treatment or interfere with the participant's ability to comply with the study protocol. * Allogeneic HSCT within 12 weeks before the start of blinatumomab.
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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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Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Kanagawa Childrens Medical Center
Yokohami-shi, Kanagawa, 232-8555, Japan
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Lucile Packard Childrens Hospital Stanford
Palo Alto, California, 94304, United States
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Seattle Childrens Hospital
Seattle, Washington, 98105, United States
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St Jude Childrens Research Hospital
Memphis, Tennessee, 38105, United States