Blinatumomab
- Generic Name
- Blinatumomab
- Brand Names
- Blincyto
- Drug Type
- Biotech
- CAS Number
- 853426-35-4
- Unique Ingredient Identifier
- 4FR53SIF3A
- Background
Blinatumomab is a BiTE-class (bi-specific T-cell engager) constructed monoclonal antibody formed by the recombinant fusion of an anti-CD3 single-chain variable fragment (scFV) and an anti-CD19 scFV through a short peptide linker. CD3 is an antigen expressed on the surface of T-cells, while CD19 is mostly expressed on the surface of malignant B-cells. Since blinatumomab has an affinity to both antigens, it redirects T-cells to tumor cells expressing CD19 and promotes tumor cell lysis and apoptosis.
Blinatumomab is manufactured by Amgen Inc. and marketed under the brand Blincyto. It was first approved by the FDA in December 2014 for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in relapsed and refractory patients. In March 2018, it was approved under the FDA’s accelerated approval program for the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children. Full approval for this indication was granted in June 2023.
Blinatumomab has a short half-life, requiring patients to receive a continuous infusion over 4-week cycles using a portable mini-pump for optimum delivery.
- Indication
Blinatumomab is indicated for the treatment of adults and children with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). It is also indicated in adults and children for the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
- Associated Conditions
- Precursor B-lymphoblastic leukaemia acute, Refractory B-cell precursor acute lymphoblastic leukemia, Relapsed B cell precursor Acute lymphoblastic leukemia
Blinatumomab Bridging Therapy for BALL
- Conditions
- B-cell Acute Lymphoblastic LeukemiaRelapsed B-cell Acute Lymphoblastic LeukemiaRefractory B Acute Lymphoblastic Leukemia
- Interventions
- First Posted Date
- 2020-09-21
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Michael Burke
- Target Recruit Count
- 2
- Registration Number
- NCT04556084
- Locations
- 🇺🇸
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Blinatumomab Followed by High-dose Chemotherapy for Ph-negative Acute Lymphoblastic Leukemia (ALL)
- Conditions
- Newly DiagnosedLymphoblastic Leukemia, Acute, AdultPh Negative ALL
- Interventions
- First Posted Date
- 2020-09-18
- Last Posted Date
- 2024-04-04
- Lead Sponsor
- Institute of Hematology and Blood Transfusion, Czech Republic
- Target Recruit Count
- 27
- Registration Number
- NCT04554485
- Locations
- 🇨🇿
University Hospital Hradec Kralove,The 4th Department of Internal Medicine - Hematology, Hradec Králové, Czechia
🇨🇿University Hospital Olomouc, Hematooncology Clinic, Olomouc, Czechia
🇨🇿University Hospital Ostrava, Hematooncology Clinic, Ostrava, Czechia
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
- Conditions
- Down SyndromeRecurrent B Acute Lymphoblastic Leukemia
- Interventions
- Procedure: Biospecimen CollectionRadiation: 3-Dimensional Conformal Radiation TherapyProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Lumbar Puncture
- First Posted Date
- 2020-09-14
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 300
- Registration Number
- NCT04546399
- Locations
- 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸USA Health Strada Patient Care Center, Mobile, Alabama, United States
🇺🇸Providence Alaska Medical Center, Anchorage, Alaska, United States
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
- Conditions
- B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration and BiopsyProcedure: Echocardiography TestProcedure: ElectrocardiographyProcedure: Lumbar PunctureProcedure: Multigated Acquisition Scan
- First Posted Date
- 2020-08-28
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 348
- Registration Number
- NCT04530565
- Locations
- 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- First Posted Date
- 2020-08-24
- Last Posted Date
- 2024-04-08
- Lead Sponsor
- Amgen
- Target Recruit Count
- 17
- Registration Number
- NCT04524455
- Locations
- 🇫🇷
Centre Hospitalier Lyon Sud, Pierre Benite, France
🇪🇸Hospital Universitari Germans Trias i Pujol, Badalona, Cataluña, Spain
🇩🇪Universitätsklinikum Schleswig-Holstein, Kiel, Germany
A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients
- Conditions
- B Cell Precursor Acute Lymphoblastic Leukemia
- Interventions
- First Posted Date
- 2020-08-20
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- Amgen
- Target Recruit Count
- 125
- Registration Number
- NCT04521231
- Locations
- 🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸Fred Hutchinson Cancer Center, Seattle, Washington, United States
Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
- Conditions
- B-precursor Acute Lymphoblastic Leukemia
- Interventions
- Device: Current Wearable Heatlth Monitoring System (CWHMS)
- First Posted Date
- 2020-08-10
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- Amgen
- Target Recruit Count
- 10
- Registration Number
- NCT04506086
- Locations
- 🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸University of California Los Angeles, Los Angeles, California, United States
🇺🇸University of California Irvine, Orange, California, United States
Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL
- First Posted Date
- 2020-06-26
- Last Posted Date
- 2022-03-02
- Lead Sponsor
- Dorothy Sipkins, MD, PhD
- Registration Number
- NCT04448834
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸Duke University, Durham, North Carolina, United States
🇺🇸Novant Health Cancer Institute and Innovation Center, Winston-Salem, North Carolina, United States
Pediatric-type Therapy With Pre-transplant Blinatumomab for HR Patients - Phase II Study
- First Posted Date
- 2020-04-06
- Last Posted Date
- 2021-05-07
- Lead Sponsor
- Israeli Medical Association
- Target Recruit Count
- 110
- Registration Number
- NCT04334993
- Locations
- 🇮🇱
Rambam Medical Center, Haifa, Israel
🇮🇱Shaarei Tzedek Medical Center, Jerusalem, Israel
🇮🇱Rabin Medical Center, Petah Tikva, Israel
Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic LeukemiaPhiladelphia Chromosome-Positive
- Interventions
- First Posted Date
- 2020-04-01
- Last Posted Date
- 2025-05-02
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 17
- Registration Number
- NCT04329325
- Locations
- 🇺🇸
Mount Sinai Hospital, New York, New York, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
Drug Development Updates
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