Blinatumomab
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Also known as AMG-103AMG103BlincytoMEDI-538MEDI538MT-103MT103
Summary
Blinatumomab (CHEMBL1742992) is an approved antibody (ATC L01FX07) targeting CD3E and CD19; indicated across 14 conditions including acute lymphoblastic leukemia and neoplasm.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L01FX07
- Targets: 2 (CD3E, CD19)
- Indications: 14 conditions
- Clinical trials: 149
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1742992 |
| Name | Blinatumomab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L01FX07 |
Also known as: AMG-103, AMG103, Blinatumomab, Blincyto, MEDI-538, MEDI538, MT-103, MT103, BLINATUMOMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| CD3E | CD3e | Binding | 7 | 0% | P07766 |
| CD19 | CD19 | Binding | 9 | 2.5% | P15391 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 2 target gene(s): CD3E, CD19.
Top Reactome pathways
24 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Adaptive Immune System | 2 | CD19, CD3E |
| Immune System | 2 | CD19, CD3E |
| Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell | 2 | CD19, CD3E |
| PIP3 activates AKT signaling | 1 | CD19 |
| Signal Transduction | 1 | CD19 |
| Disease | 1 | CD19 |
| Complement cascade | 1 | CD19 |
| Innate Immune System | 1 | CD19 |
| Negative regulation of the PI3K/AKT network | 1 | CD19 |
| TCR signaling | 1 | CD3E |
| Downstream TCR signaling | 1 | CD3E |
| Phosphorylation of CD3 and TCR zeta chains | 1 | CD3E |
| Translocation of ZAP-70 to Immunological synapse | 1 | CD3E |
| Generation of second messenger molecules | 1 | CD3E |
| PI3K/AKT Signaling in Cancer | 1 | CD19 |
| Constitutive Signaling by Aberrant PI3K in Cancer | 1 | CD19 |
| Regulation of T cell activation by CD28 family | 1 | CD3E |
| Co-inhibition by PD-1 | 1 | CD3E |
| Diseases of signal transduction by growth factor receptors and second messengers | 1 | CD19 |
| PI5P, PP2A and IER3 Regulate PI3K/AKT Signaling | 1 | CD19 |
| Intracellular signaling by second messengers | 1 | CD19 |
| Regulation of Complement cascade | 1 | CD19 |
| Antigen activates B Cell Receptor (BCR) leading to generation of second messengers | 1 | CD19 |
| Signaling by the B Cell Receptor (BCR) | 1 | CD19 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| adaptive immune response | 2 |
| immune system process | 2 |
| positive regulation of cell-matrix adhesion | 1 |
| positive regulation of T cell anergy | 1 |
| T cell anergy | 1 |
| cell surface receptor signaling pathway | 1 |
| cell surface receptor protein tyrosine kinase signaling pathway | 1 |
| signal complex assembly | 1 |
| G protein-coupled receptor signaling pathway | 1 |
| smoothened signaling pathway | 1 |
| positive regulation of gene expression | 1 |
| negative regulation of gene expression | 1 |
| dendrite development | 1 |
| calcium-mediated signaling | 1 |
| cerebellum development | 1 |
Indications & clinical
Indications
14 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| acute lymphoblastic leukemia | 4 | MONDO:0004967 | EFO:0000220 |
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| lymphoid leukemia | 4 | MONDO:0005402 | EFO:0004289 |
| leukemia | 3 | MONDO:0005059 | EFO:0000565 |
| B-cell acute lymphoblastic leukemia | 2 | MONDO:0004947 | EFO:0000094 |
| diffuse large B-cell lymphoma | 2 | MONDO:0018905 | EFO:0000403 |
| non-Hodgkin lymphoma | 2 | MONDO:0018908 | EFO:0005952 |
| T-cell acute lymphoblastic leukemia | 2 | MONDO:0004963 | EFO:0000209 |
| lymphoid neoplasm | 2 | MONDO:0005157 | EFO:0001642 |
| B-cell chronic lymphocytic leukemia | 1 | MONDO:0004948 | EFO:0000095 |
| lymphoma | 1 | MONDO:0005062 | EFO:0000574 |
| Burkitt lymphoma | 1 | MONDO:0007243 | EFO:0000309 |
| plasma cell myeloma | 0 | MONDO:0009693 | EFO:0001378 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 149.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 66 |
| PHASE1 | 23 |
| PHASE1/PHASE2 | 18 |
| PHASE3 | 16 |
| Not specified | 14 |
| PHASE2/PHASE3 | 9 |
| PHASE4 | 2 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06339775 | PHASE4 | RECRUITING | Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation |
| NCT04506086 | PHASE4 | TERMINATED | Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) |
| NCT02003222 | PHASE3 | ACTIVE_NOT_RECRUITING | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT02101853 | PHASE3 | ACTIVE_NOT_RECRUITING | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT03117751 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma |
| NCT03643276 | PHASE3 | RECRUITING | Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 |
| NCT03914625 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT03959085 | PHASE3 | RECRUITING | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT04307576 | PHASE3 | RECRUITING | A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia |
| NCT04530565 | PHASE3 | ACTIVE_NOT_RECRUITING | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT04722848 | PHASE3 | ACTIVE_NOT_RECRUITING | Sequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph+ ALL |
| NCT04994717 | PHASE3 | ACTIVE_NOT_RECRUITING | Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia |
| NCT05327894 | PHASE3 | RECRUITING | Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia |
| NCT06607419 | PHASE2/PHASE3 | RECRUITING | Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia |
| NCT06684184 | PHASE2/PHASE3 | NOT_YET_RECRUITING | Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG) |
| NCT06836973 | PHASE2/PHASE3 | NOT_YET_RECRUITING | Blinatumomab for Treatment of Refractory Myasthenia Gravis |
| NCT06860269 | PHASE2/PHASE3 | RECRUITING | A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia |
| NCT06882057 | PHASE2/PHASE3 | RECRUITING | Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol |
| NCT07223190 | PHASE3 | NOT_YET_RECRUITING | A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia |
| NCT07297914 | PHASE2/PHASE3 | NOT_YET_RECRUITING | Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL |
| NCT07476729 | PHASE3 | NOT_YET_RECRUITING | International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) |
| NCT07570173 | PHASE2/PHASE3 | RECRUITING | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT02013167 | PHASE3 | TERMINATED | Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) |
| NCT02393859 | PHASE3 | COMPLETED | Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) |
| NCT02910063 | PHASE2/PHASE3 | COMPLETED | Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL |
| NCT03476239 | PHASE3 | COMPLETED | Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) |
| NCT03628053 | PHASE3 | WITHDRAWN | Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia |
| NCT01371630 | PHASE1/PHASE2 | RECRUITING | Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT02143414 | PHASE2 | ACTIVE_NOT_RECRUITING | Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia |
| NCT02790515 | PHASE2 | ACTIVE_NOT_RECRUITING | Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation |
| NCT02877303 | PHASE2 | RECRUITING | Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT03114865 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance |
| NCT03147612 | PHASE2 | ACTIVE_NOT_RECRUITING | Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia |
| NCT03263572 | PHASE2 | RECRUITING | Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia |
| NCT03512405 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Pembrolizumab and Blinatumomab in Treating Participants With Recurrent or Refractory Acute Lymphoblastic Leukemia |
| NCT03541083 | PHASE2 | ACTIVE_NOT_RECRUITING | Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults. |
| NCT03709719 | PHASE2 | ACTIVE_NOT_RECRUITING | Blinatumomab in High-risk B-cell Precursor Acute Lymphoblastic Leukemia |
| NCT03739814 | PHASE2 | RECRUITING | Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia |
| NCT03849651 | PHASE2 | ACTIVE_NOT_RECRUITING | TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies |
| NCT04329325 | PHASE2 | ACTIVE_NOT_RECRUITING | Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Genes: CD3E, CD19
- Diseases: acute lymphoblastic leukemia, neoplasm, lymphoid leukemia, leukemia