RecruitingPhase 1Phase 2NCT07134088

A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)


Sponsor

Amgen

Enrollment

104 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.


Eligibility

Min Age: 28 DaysMax Age: 4383 Days

Plain Language Summary

Simplified for easier understanding

This study is testing a new form of blinatumomab — a drug that helps immune cells find and destroy cancer cells — given as a subcutaneous (under-the-skin) injection rather than intravenously, in children with relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (B-ALL), a type of childhood blood cancer. **You may be eligible if...** - Your child is between 28 days old and under 12 years old - Your child has B-cell acute lymphoblastic leukemia (B-ALL) that has come back or stopped responding to treatment - Your child is reasonably active and functional - Prior CD19-targeted therapy (like certain CAR-T treatments) is allowed if the cancer still has CD19 markers and treatment has ended at least 30 days ago - For MRD-positive B-ALL: your child has a low but detectable level of leukemia cells in the bone marrow **You may NOT be eligible if...** - Your child is 12 or older - Your child has active CNS (brain/spinal fluid) involvement by leukemia - Your child has had a recent stem cell transplant without adequate recovery time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBlinatumomab

Blinatumomab will be administered as a SC injection for up to 5 cycles (each cycle will be 35 days).


Locations(4)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St Jude Childrens Research Hospital

Memphis, Tennessee, United States

Seattle Childrens Hospital

Seattle, Washington, United States

Kanagawa Childrens Medical Center

Yokohami-shi, Kanagawa, Japan

View Full Details on ClinicalTrials.gov

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NCT07134088