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Moxetumomab pasudotox

Generic Name
Moxetumomab pasudotox
Brand Names
Lumoxiti
Drug Type
Biotech
CAS Number
1020748-57-5
Unique Ingredient Identifier
2NDX4B6N8F
Background

CD22 is a lineage-restricted B-cell antigen that is expressed solely in on B-chronic lymphocytic leukemia, hairy cell leukemia, acute lymphocytic leukemiathe and Burkitt's lymphoma. The predecessor of Moxetumab pasudotox (MxP), named BL22, was first created based on the antibody RFB4 which specifically binds to CD22. This antibody was used to generate a recombinant immunotoxin in which a stabilized Fv segment by a disulfide bond is fused to the Pseudomonas exotoxin A (PE38) which does not have the cell-binding portion.

MxP appears as an improved form of BL22 by the mutation of the Fv region and the antibody phage-displayed. As well the residues SSY in the heavy chain are mutated to THW. It was developed by Astra Zeneca and FDA approved on September 13, 2018, after being granted the status of Fast Track, Priority Review and Orphan Drug designations.

Indication

MxP is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies including treatment with a purine nucleoside analog. The use of this drug is not recommended in patients with severe renal impairment (CrCl < 29 ml/min).

HCL is an uncommon type of lymphocytic leukemia that starts in B cells or B lymphocytes. It is characterized by an accumulation of abnormal B lymphocytes. HCL is called "hairy" as it produces hair-like projections in the surface of the cancer cells. A usual symptom in people having HCL is the presence of splenomegaly and less often hepatomegaly.

Associated Conditions
Relapsed/Refractory Hairy Cell Leukemia

Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia

Phase 1
Active, not recruiting
Conditions
Hairy Cell Leukemia
Interventions
First Posted Date
2019-01-16
Last Posted Date
2024-07-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
18
Registration Number
NCT03805932
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia

Conditions
Relapsed/Refractory Hairy Cell Leukemia
First Posted Date
2018-04-18
Last Posted Date
2020-06-29
Lead Sponsor
AstraZeneca
Registration Number
NCT03501615

Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma

Phase 2
Terminated
Conditions
B-Cell Pediatric ALL
Interventions
First Posted Date
2014-08-27
Last Posted Date
2017-04-06
Lead Sponsor
MedImmune LLC
Target Recruit Count
37
Registration Number
NCT02227108
Locations
🇬🇧

Research Site, Bristol, United Kingdom

Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)

Phase 1
Terminated
Conditions
Leukemia
Interventions
First Posted Date
2013-07-03
Last Posted Date
2023-10-13
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
16
Registration Number
NCT01891981
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia

Phase 3
Completed
Conditions
Leukemia, Hairy Cell
Interventions
Drug: IV Bag Protectant for Moxetumomab pasudotox
First Posted Date
2013-04-11
Last Posted Date
2020-04-08
Lead Sponsor
MedImmune LLC
Target Recruit Count
80
Registration Number
NCT01829711
Locations
🇬🇧

Research Site, Sutton, United Kingdom

A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Non-Hodgkin's Lymphoma (NHL)

Phase 1
Terminated
Conditions
Lymphoma
Interventions
First Posted Date
2008-01-07
Last Posted Date
2011-11-22
Lead Sponsor
MedImmune LLC
Target Recruit Count
50
Registration Number
NCT00587015
Locations
🇺🇸

Tower Hematology Oncology Medical Group, Beverly Hills, California, United States

🇵🇱

Kalinika Hemotologii Uniwersytetu Medycznego, Lodz, Poland

🇺🇸

NCI, National Institutes of Health, Bethesda, Maryland, United States

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