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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL (NCT04521231) is a Phase 1 / Phase 2 interventional studying B Cell Precursor Acute Lymphoblastic Leukemia, sponsored by Amgen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For B Cell Precursor Acute Lymphoblastic Leukemia, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 281 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused B Cell Precursor Acute Lymphoblastic Leukemia subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Ph-IIC, Dose Escalation and Dose Expansion: Aged 18 years or older (or same or greater than legal age within the country if it is older than 18 years). - Ph-IIRa and Ph-IIMa: Aged ≥ 17 years at time of willing to sign a consent form. - Ph-IIRb and Ph-IIMb: Age ≥ 12 years and \< 17 years at time of willing to sign a consent form. - Ph-IIR, Ph-IIC, Dose escalation, Dose Expansion: Participants with R/R B-precursor ALL. - Relapsed or Refractory B-precursor ALL at any time after first salvage therapy. - Relapsed B-precursor ALL at any time after allogenic hematopoietic stem cell transplant (HSCT). - Ph-IIR, Ph-IIC, Dose escalation, Dose expansion: Greater than or equal to 5% blasts in the Bone Marrow per local assessment. - Ph-IIM: B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and \< 5% per local assessment. - Ph-IIM: Availability of an appropriate archival BM specimen from initial or relapse diagnosis and the screening BM sample. - Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. - Participants aged 16 to \< 18 years old: Karnofsky Performance Score ≥ 50%. - Participants aged \< 16 years old: Lansky Performance Score ≥ 50%. - Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible. - Ph-IIM: BM function as follows: - Absolute Neutrophil Count (ANC) ≥ 500/μL - Platelet count ≥ 50 000/μL (transfusion permitted) - Hemoglobin level ≥ 9 g/dL (transfusion permitted) The above is a summary, other inclusion criteria details may apply. Who Should NOT Join This Trial: - Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia. If CSF leukemia is present subjects will have to receive intrathecal therapy and have documented negative CSF prior to enrolling. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Ph-IIC, Dose Escalation and Dose Expansion: Aged 18 years or older (or same or greater than legal age within the country if it is older than 18 years). * Ph-IIRa and Ph-IIMa: Aged ≥ 17 years at time of informed consent. * Ph-IIRb and Ph-IIMb: Age ≥ 12 years and \< 17 years at time of informed consent. * Ph-IIR, Ph-IIC, Dose escalation, Dose Expansion: Participants with R/R B-precursor ALL. * Relapsed or Refractory B-precursor ALL at any time after first salvage therapy. * Relapsed B-precursor ALL at any time after allogenic hematopoietic stem cell transplant (HSCT). * Ph-IIR, Ph-IIC, Dose escalation, Dose expansion: Greater than or equal to 5% blasts in the Bone Marrow per local assessment. * Ph-IIM: B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and \< 5% per local assessment. * Ph-IIM: Availability of an appropriate archival BM specimen from initial or relapse diagnosis and the screening BM sample. * Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. * Participants aged 16 to \< 18 years old: Karnofsky Performance Score ≥ 50%. * Participants aged \< 16 years old: Lansky Performance Score ≥ 50%. * Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible. * Ph-IIM: BM function as follows: * Absolute Neutrophil Count (ANC) ≥ 500/μL * Platelet count ≥ 50 000/μL (transfusion permitted) * Hemoglobin level ≥ 9 g/dL (transfusion permitted) The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia. If CSF leukemia is present subjects will have to receive intrathecal therapy and have documented negative CSF prior to enrolling. * History or presence of clinically relevant CNS pathology (excluding headache) such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including immune effector cell-associated neurotoxicity syndrome (ICANS) from prior chimeric antigen receptor T-cell (CAR T) or other T cell engager therapies. * Isolated Extramedullary (EM) Disease. * For Ph-IIM only: Current EM disease or presence of circulating leukemia blasts. * Current autoimmune disease or history of autoimmune disease with potential CNS involvement. * Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication. * Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any other disease or condition that could be exacerbated by the treatment or would complicate protocol compliance. * Testicular leukemia. * History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy. * Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy. * Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions). * Immunotherapy within 4 weeks before start of protocol-specified therapy. * Prior failed cluster of differentiation (CD19) directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed (with demonstrated continued CD19+ expression), if treatment ended more than 4 weeks prior to start of protocol therapy and no prior CNS complications. * Currently receiving treatment in or less than 30 days or 5 half-lives since ending treatment on another investigational study(ies). * Abnormal screening laboratory parameters. * Female participant: Pregnant or breastfeeding or planning to become pregnant or donate eggs, or expected to breastfeed during treatment and for 96 hours after the last dose of investigational product (SC blinatumomab). The above is a summary, other exclusion criteria details may apply.

Treatments Being Tested

DRUG

Blinatumomab

Blinatumomab will be administered as a subcutaneous (SC) injection.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

City of Hope National Medical Center
Duarte, California, United States
University of Illinois Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
C.S. Mott Children's Hospital - University of Michigan
Ann Arbor, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States
Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York, United States
St Jude Childrens Research Hospital
Memphis, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Allende
Córdoba, Córdoba Province, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno
Ciudad Autonoma Buenos Aires, Argentina
Sydney Childrens Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04521231), the sponsor (Amgen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04521231 clinical trial studying?

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharma… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04521231?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04521231?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04521231. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04521231. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.