MedPath

Blinatumomab

Generic Name
Blinatumomab
Brand Names
Blincyto
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-

Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

Phase 3
Recruiting
Conditions
Acute Lymphoblastic Leukemia
Mixed Phenotype Acute Leukemia
Interventions
First Posted Date
2022-04-14
Last Posted Date
2025-01-09
Lead Sponsor
Princess Maxima Center for Pediatric Oncology
Target Recruit Count
160
Registration Number
NCT05327894
Locations
🇦🇷

Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan", Buenos Aires, Argentina

🇦🇺

Australian and New Zealand Children's Haematology/Oncology Group, Clayton, Victoria, Australia

🇦🇺

North Adelaide- Womens and Childrens Hospital, Adelaide, Australia

and more 73 locations

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

First Posted Date
2022-01-14
Last Posted Date
2024-11-26
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
35
Registration Number
NCT05192889
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Venetoclax in Addition to Blinatumomab in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)

Phase 1
Recruiting
Conditions
ALL, Recurrent, Adult
Interventions
First Posted Date
2022-01-10
Last Posted Date
2024-05-22
Lead Sponsor
Goethe University
Target Recruit Count
39
Registration Number
NCT05182385
Locations
🇩🇪

Charité - Campus Benjamin Franklin, Berlin, Germany

🇩🇪

University Hospital of Frankfurt (Main), Frankfurt (Main), Hessen, Germany

🇩🇪

Universitätsklinikum Essen, Essen, Germany

and more 14 locations

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

Phase 3
Recruiting
Conditions
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Interventions
Drug: SOC chemotherapy regimen
Drug: Blinatumomab
Drug: Low-intensity chemotherapy regimen
First Posted Date
2021-08-06
Last Posted Date
2025-01-03
Lead Sponsor
Amgen
Target Recruit Count
287
Registration Number
NCT04994717
Locations
🇯🇵

Tohoku University Hospital, Sendai-shi, Miyagi, Japan

🇯🇵

Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan

🇺🇸

City of Hope National Medical Center, Duarte, California, United States

and more 159 locations

ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

Phase 2
Terminated
Conditions
ALL, Childhood
Minimal Residual Disease
Interventions
First Posted Date
2021-03-08
Last Posted Date
2024-01-16
Lead Sponsor
Prof. Christina Peters
Target Recruit Count
3
Registration Number
NCT04785547
Locations
🇳🇴

Oslo University Hospital, Oslo, Norway

🇮🇹

IRCCS Ospedale Pediatrico Bambino Gesù Roma, Roma, Italy

🇵🇱

Nicolaus Copernicus University Collegium Medicum, Bydgoszcz, Poland

and more 11 locations

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Phase 2
Recruiting
Conditions
B-cell Childhood Acute Lymphoblastic Leukemia
B-cell Acute Lymphoblastic Leukemia
B-Cell ALL, Childhood
Interventions
Device: Alpha/Beta T-cell and B-cell depleted HCT
Drug: Blinatumomab
First Posted Date
2021-02-09
Last Posted Date
2021-09-17
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
25
Registration Number
NCT04746209
Locations
🇺🇸

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

Not Applicable
Recruiting
Conditions
Childhood Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2021-01-25
Last Posted Date
2021-01-25
Lead Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Target Recruit Count
180
Registration Number
NCT04723342
Locations
🇷🇺

Almazov National Medical Research Centre, Saint Petersburg, Russian Federation

🇷🇺

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation

🇷🇺

National Medical Research Center of Oncology named after N.N. Blokhin, Moscow, Russian Federation

and more 1 locations

Study in Adult Ph-positive ALL

Phase 2
Not yet recruiting
Conditions
Acute Lymphoblastic Leukemia, Adult
Interventions
First Posted Date
2020-12-30
Last Posted Date
2020-12-30
Lead Sponsor
Cardiff University
Target Recruit Count
180
Registration Number
NCT04688983

Blinatumomab Bridging Therapy

Phase 2
Recruiting
Conditions
B-cell Acute Lymphoblastic Leukemia
Relapsed B-cell Acute Lymphoblastic Leukemia
Refractory B Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2020-09-21
Last Posted Date
2022-04-05
Lead Sponsor
Michael Burke
Target Recruit Count
35
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)

Phase 2
Completed
Conditions
Newly Diagnosed
Lymphoblastic Leukemia, Acute, Adult
Ph 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

and more 2 locations
© Copyright 2025. All Rights Reserved by MedPath