Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic LeukemiaPhase 1/2NCT07134088
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Blinatumomab in people with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia and Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia, run by Amgen at 5 sites in 2 countries.
Trial summary
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Dec 2025to 16 Sep 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
Lucile Packard Childrens Hospital Stanford
Palo Alto, California, 94304
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Childrens Hospital
Seattle, Washington, 98105
About this study
Official title: 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)
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
- Being tested
- Blinatumomab
- 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
- Medical subject headings
- Recurrence, Neoplasm, Residual, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Blinatumomab will be administered as a SC injection for up to 5 cycles (each cycle will be 35 days).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Blinatumomab |
| Cohort Ph2-R | Experimental | Participants with R/R B-ALL will receive blinatumomab as SC injection at RP2D. Receives: Drug: Blinatumomab |
| Cohort Ph2-M | Experimental | Participants with MRD+ B-ALL will receive blinatumomab as SC injection at RP2D. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Measured: Up to 29 days
Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced Serious TEAEs
Measured: Up to 2 years and 7 months
Phase 1b: Number of Participants who Experienced Treatment-related TEAEs
Measured: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)
Measured: 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
Measured: 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%).
Measured: Up to 70 days
Secondary outcomes (18)
Phase 1b: Number of Participants who had CR/CRh Within the First 2 Cycles
Measured: Up to 70 days
Phase 1b: Number of Participants who had CR Within the First 2 Cycles
Measured: 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
Measured: Up to 70 days
Phase 1b: Number of Participants with a MRD Negative Response Within the First 2 Cycles
MRD negative response = MRD level < 10^-4 (0.01%).
Measured: Up to 70 days
Phase 1b: Duration of Response (DOR)
DOR is defined as the time from the first response of CR/CRh within the first 2 cycles until hematological relapse (Including extramedullary [EM] relapse) per investigator's assessment or death due to any cause, whichever occurs first.
Measured: Up to 2 years and 7 months
Phase 1b: Maximum Concentration (Cmax) of Blinatumomab
Measured: Up to approximately 7 months
Phase 1b: Time to Maximum Concentration (Tmax)
Measured: Up to approximately 7 months
Phase 1b: Area Under the Concentration Time Curve (AUC)
Measured: Up to approximately 7 months
Phase 1b: Number of Participants with Anti-blinatumomab Antibodies
Measured: Cycle 1, Day 1 and Cycle 2, Day 1 (Cycle Duration = 35 days)
Phase 2: Number of Participants who had CR/CRh with MRD Negative Response Within the First 2 Cycles
MRD negative response = MRD level < 10^-4 (0.01%).
Measured: Up to 70 days
Phase 2: DOR
DOR is defined as the time from the first response of CR/CRh within the first 2 cycles until hematological relapse (Including EM relapse) per investigator's assessment or death due to any cause, whichever occurs first.
Measured: Up to 2 years and 7 months
Phase 2; R Cohort: Number of participants who had CR Within the First 2 Cycles
Measured: Up to 70 days
Phase 2; R Cohort: Number of participants who had CR/CRh/CRi and Blast Free Hypoplastic or Aplastic BM Within the First 2 Cycles
Measured: Up to 70 days
Phase 2: Overall Survival (OS)
OS is defined as the time from the first dose until death due to any cause.
Measured: Up to 2 years and 7 months
Phase 2: Number of Participants who Experienced TEAEs, Serious TEAEs, Treatment Related TEAEs and EOIs
Measured: Up to 2 years and 7 months
Phase 2: Blinatumomab Serum Concentrations
Measured: Up to 175 days
Phase 2: Number of Participants with Anti-blinatumomab Antibodies
Measured: Cycle 1, Day 1 and Cycle 2, Day 1 (Cycle Duration = 35 days)
Phase 2; M Cohort: Number of participants who had CR/CRh/CRi and Blast Free Hypoplastic or Aplastic BM with MRD Negative Response Within the First 2 Cycles
MRD negative response = MRD level < 10^-4 (0.01%).
Measured: Up to 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start8 Dec 2025
- Primary completion6 Mar 2031 (estimated)
- Study completion16 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134088
- Sponsor's protocol ID
- 20220107
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07134088
- Acronym / sponsor ID
- 20220107
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 6 Mar 2031 (estimated)
- Study completion
- 16 Sep 2032 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: R/R B-ALL | Experimental | Drug: BlinatumomabParticipants with R/R B-ALL will receive blinatumomab as SC injection to determine the pediatric recommended Phase 2 dose (RP2D). |
| Cohort Ph2-R | Experimental | Drug: BlinatumomabParticipants with R/R B-ALL will receive blinatumomab as SC injection at RP2D. |
| Cohort Ph2-M | Experimental | Drug: BlinatumomabParticipants with MRD+ B-ALL will receive blinatumomab as SC injection at RP2D. |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- For Phase 2 cohort in participants with MRD+ B-ALL:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabBlinatumomab will be administered as a SC injection for up to 5 cycles (each cycle will be 35 days). | Drug | Cohort Ph2-M, Cohort Ph2-R, Phase 1b: R/R B-ALL |
Primary outcome
Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Time frame: Up to 29 days
Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced Serious TEAEs
Time frame: Up to 2 years and 7 months
Phase 1b: Number of Participants who Experienced Treatment-related TEAEs
Time frame: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)
Time frame: 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
Time frame: Up to 70 days
Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles
Time frame: Up to 70 days
MRD negative response = MRD level < 10^-4 (0.01%).
18 secondary outcomes
Phase 1b: Number of Participants who had CR/CRh Within the First 2 Cycles
Time frame: Up to 70 days
Phase 1b: Number of Participants who had CR Within the First 2 Cycles
Time frame: 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
Time frame: Up to 70 days
Phase 1b: Number of Participants with a MRD Negative Response Within the First 2 Cycles
Time frame: Up to 70 days
Phase 1b: Duration of Response (DOR)
Time frame: Up to 2 years and 7 months
Phase 1b: Maximum Concentration (Cmax) of Blinatumomab
Time frame: Up to approximately 7 months
Phase 1b: Time to Maximum Concentration (Tmax)
Time frame: Up to approximately 7 months
Phase 1b: Area Under the Concentration Time Curve (AUC)
Time frame: Up to approximately 7 months
Phase 1b: Number of Participants with Anti-blinatumomab Antibodies
Time frame: Cycle 1, Day 1 and Cycle 2, Day 1 (Cycle Duration = 35 days)
Phase 2: Number of Participants who had CR/CRh with MRD Negative Response Within the First 2 Cycles
Time frame: Up to 70 days
Phase 2: DOR
Time frame: Up to 2 years and 7 months
Phase 2; R Cohort: Number of participants who had CR Within the First 2 Cycles
Time frame: Up to 70 days
Phase 2; R Cohort: Number of participants who had CR/CRh/CRi and Blast Free Hypoplastic or Aplastic BM Within the First 2 Cycles
Time frame: Up to 70 days
Phase 2: Overall Survival (OS)
Time frame: Up to 2 years and 7 months
Phase 2: Number of Participants who Experienced TEAEs, Serious TEAEs, Treatment Related TEAEs and EOIs
Time frame: Up to 2 years and 7 months
Phase 2: Blinatumomab Serum Concentrations
Time frame: Up to 175 days
Phase 2: Number of Participants with Anti-blinatumomab Antibodies
Time frame: Cycle 1, Day 1 and Cycle 2, Day 1 (Cycle Duration = 35 days)
Phase 2; M Cohort: Number of participants who had CR/CRh/CRi and Blast Free Hypoplastic or Aplastic BM with MRD Negative Response Within the First 2 Cycles
Time frame: Up to 70 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Blinatumomab in people with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia and Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia, run by Amgen at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs) (time frame: Up to 29 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.