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

NCT07134088 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20220107
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia; Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia

Keywords

Blinatumomab; AMG 103; Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia; Minimal Residual Disease Positive B-Cell Precursor Acute Lymphoblastic Leukemia; R/R B-ALL; MRD+ B-ALL

Outcome Measures

Primary Outcomes (7)

• Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)

  Up to 29 days

• Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

  Up to approximately 7 months

• Phase 1b: Number of Participants who Experienced Serious TEAEs

  Up to 2 years and 7 months

• Phase 1b: Number of Participants who Experienced Treatment-related TEAEs

  Up to approximately 7 months

• Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)

  Up to approximately 7 months

• Phase 2; R Cohort: Number of Participants who had Complete Remission/Complete Remission with Partial Hematological Recovery (CR/CRh) Within the First 2 Cycles

  Up to 70 days

• Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles

  MRD negative response = MRD level \< 10\^-4 (0.01%).

  Up to 70 days

Secondary Outcomes (18)

• Phase 1b: Number of Participants who had CR/CRh Within the First 2 Cycles

  Up to 70 days

• Phase 1b: Number of Participants who had CR Within the First 2 Cycles

  Up to 70 days

• Phase 1b: Number of Participants who had CR/CRh/Complete Remission with Incomplete Hematological Recovery (CRi) or Blast Free Hypoplastic or Aplastic Bone Marrow (BM) Within the First 2 Cycles

  Up to 70 days

• Phase 1b: Number of Participants with a MRD Negative Response Within the First 2 Cycles

  Up to 70 days

• Phase 1b: Duration of Response (DOR)

  Up to 2 years and 7 months

Study Arms (3)

Phase 1b: R/R B-ALL

EXPERIMENTAL

Participants with R/R B-ALL will receive blinatumomab as SC injection to determine the pediatric recommended Phase 2 dose (RP2D).

Drug: Blinatumomab

Cohort Ph2-R

EXPERIMENTAL

Participants with R/R B-ALL will receive blinatumomab as SC injection at RP2D.

Drug: Blinatumomab

Cohort Ph2-M

EXPERIMENTAL

Participants with MRD+ B-ALL will receive blinatumomab as SC injection at RP2D.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

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

Cohort Ph2-M; Cohort Ph2-R; Phase 1b: R/R B-ALL

Eligibility Criteria

• Age: 28 Days - 4383 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead
• BeOne Medicines: collaborator

Study Sites (4)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

St Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Seattle Childrens Hospital

Seattle, Washington, 98105, United States

RECRUITING

Kanagawa Childrens Medical Center

Yokohami-shi, Kanagawa, 232-8555, Japan

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Recurrence; Neoplasm, Residual; Burkitt Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 5, 2028
• Study Completion (Estimated): June 18, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

JP (1); US (3)