Antibody Information

General Information of This Antibody
Antibody ID
ANI0NZMLO
Antibody Name
Moxetumomab
Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Chimeric IgG1-kappa
Antigen Name
B-cell receptor CD22 (CD22)
  Antigen Info 
ChEMBI ID
CHEMBL1743043
Click to Show/Hide the Sequence Information of This Antibody
Heavy Chain Sequence
MEVQLVESGGGLVKPGGSLKLSCAASGFAFSIYDMSWVRQTPEKCLEWVAYISSGGGTTY
YPDTVKGRFTISRDNAKNTLYLQMSSLKSEDTAMYYCARHSGYGTHWGVLFAYWGQGTLV
SAKASGGPEGGSLAALTAHQACHLPLETFTRHRQPRGWEQLEQCGYPVQRLVALYIAARL
SWNQVDQVIRALASPGSGGDLGEAIREQPEQARLALTLAAAESERFVRQGTGNDEAGAAN
GPADSGDALLERNYPTGAEFLGDGGDVSFSTRGTQNWTVERLLQAHRQLEERGYVFVGYH
GTFLEAAQSIVFGGVRARSQDLDAIWRGFYIAGDPALAYGYAQDQEPDARGRIRNGALLR
VYVPRSSLPGFYRTSLTLAAPEAAGEVERLIGHPLPLRLDAITGPEEEGGRLETILGWPL
AERTWIPSAIPTDPRNVGGDLDPSSIPDKEQAISALPDYASQPGKPPREDLK
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Light Chain Sequence
PEGGSLAALTAHQACHLPLETFTRHRQPRGWEQLEQCGYPVQRLVALYLAARLSWNQVDQ
VIRNALASPGSGGDLGEAIREQPEQARLALTLAAAESERFVRQGTGNDEAGAANGPADSG
DALLERNYPTGAEFLGDGGDVSFSTRGTQNWTVERLLQAHRQLEERGYVFVGYHGTFLEA
AQSIVFGGVRARSQDLDAIWRGFYIAGDPALAYGYAQDQEPDARGRIRNGALLRVYVPRS
SLPGFYRTSLTLAAPEAAGEVERLIGHPLPLRLDAITGPEEEGGRLETILGWPLAERTVV
IPSAIPTDPRNVGGDLDPSSIPDKEQAISALPDYASQPGKPPREDLK
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Moxetumomab pasudotox [Approved]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 7 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
75.00%
Patients Enrolled
Hairy cell leukemia (HCL) patients have received at least two prior systemic therapies, including two courses of a purine nucleoside analog or one course of rituximab or a BRAF inhibitor following a single prior purine nucleoside analog course.
Administration Dosage
40 ug/kg intravenously on days 1, 3, and 5 every 28 days for 6 cycles.
Related Clinical Trial
NCT Number NCT01829711  Clinical Status Phase 3
Clinical Description
A pivotal multicenter trial of moxetumomab pasudotox in relapsed/ refractory hairy cell leukemia.
Primary Endpoint
The durable complete response rate was 30.00% (24/80 patients; 95% CI, 20.30 to 41.30).
Other Endpoint
Objective response rate was 75.00% (60/80 patients, 95% CI, 64.10 to 84.00).The complete response rate was 41.25% (33/80 patients; 95% CI, 30.40 to 52.80).
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Objective Response Rate (ORR)
78.75%
Patients Enrolled
Patients with relapsed/refractory (R/R) hairy cell leukemia (HCL) had received prior systemic therapies, including purine nucleoside analogs (PNAs), or1 PNA followed by rituximab or a BRAF inhibitor.
Administration Dosage
40 ug/kg intravenously on Days 1, 3, and 5 of each 28-day cycle for up to six cycles.
Related Clinical Trial
NCT Number NCT01829711  Clinical Status Phase 3
Clinical Description
A pivotal multicenter trial of moxetumomab pasudotox in relapsed/ refractory hairy cell leukemia.
Primary Endpoint
The durable CR rate was 49% (39 patients; 95% CI, 37-60%).
Other Endpoint
The CR rate with HR 360 days was 45.00% (36 patients; 95% CI 34.00-57.00%). The Objective response rate was 78.75% (63 patients; 95% CI 68.00-87.00%). Both the median CR duration and median HR duration from the onset of CR were 62.80 months( 95% CI, 35.70-62.80%). The median OR duration was 66.70 months, and the median HR duration from the onset of HR was 45.80 months (95% CI, 26.50-NR%). Median PFS was 41.50 months( 95% CI, 29.50-NR%).

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Experiment 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR)
13.00%
Patients Enrolled
Previously treated relapsed or refractory B-cell acute lymphocytic leukemia (ALL).
Administration Dosage
30 ug/kg (n = 6), 40 ug/kg (n = 4), and 50 ug/kg (n = 6) given intravenously over 30 min every other day 6 doses, with cycle length of 21 days.
Related Clinical Trial
NCT Number NCT01891981  Clinical Status Phase 1
Clinical Description
Phase 1/2 study of moxetumomab pasudotox in patients with relapsed and/or refractory acute lymphoblastic leukemia (ALL).
Primary Endpoint
Dose limiting toxicities (DLTs) and maximum tolerated dose (MTD). Only one DLT was observed. No treatment-related deaths were observed, and the MTD was not reached.
Experiment 4 Reporting the Activity Date of This ADC [4]
Efficacy Data Objective Response Rate (ORR)
88.00%
Patients Enrolled
Relapsed/refractory hairy cell leukemia.
Administration Dosage
50 ug/kg every other day for 3 doses in 4-week cycles.
Related Clinical Trial
NCT Number NCT00586924  Clinical Status Phase 1
Clinical Description
A phase 1, multicenter, dose escalation study of CAT-8015 in patients with relapsed or refractory hairy cell leukemia (HCL).
Experiment 5 Reporting the Activity Date of This ADC [5]
Efficacy Data Objective Response Rate (ORR)
100.00% (Dose Level in 5 ug/kg)
100.00% (Dose Level in 10 ug/kg)
67.00% (Dose Level in 20 ug/kg)
67.00% (Dose Level in 30 ug/kg)
75.00% (Dose Level in 40 ug/kg)
92.00% (Dose Level in 50 ug/kg)
Patients Enrolled
Relapsed/refractory hairy cell leukemia (HCL) after two prior therapies and required treatment because of abnormal blood counts.
Administration Dosage
5, 10, 20, and 30 ug/kg, four patients at 40 ug/kg, and 12 patients at 50 ug/kg QOD 3 for one to 16 cycles each (median, four cycles).
Related Clinical Trial
NCT Number NCT00462189  Clinical Status Phase 1
Clinical Description
A phase 1, multicenter, dose escalation study of CAT-8015 in patient with relapsed or refractory hairy cell leukemia (HCL).
Primary Endpoint
Dose Level in 5 ug/kg QODx3 (N=3, PR=100.00%, ORR=100.00%); Dose Level in 10 ug/kg QODx3(N=3, CR=67.00%,PR=33.00%, ORR=100.00%); Dose Level in 20 ug/kg QODx3 (N=3, CR=67.00%, ORR=67.00%);Dose Level in 30 ug/kg QODx3 (N=3, CR=33.00%, PR=33.00%, ORR=67.00%); Dose Level in 40 ug/kg QODx3 (N=3, CR=50.00%, PR=25.00%, ORR=75.00%); Dose Level in 50 ug/kg QODx3 (N=3, CR=50.00%, PR=42.00%, ORR=92.00%).

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Experiment 6 Reporting the Activity Date of This ADC [6]
Efficacy Data Complete Remission (CR)
10.71%
Patients Enrolled
Relapsed or chemotherapy-refractory precursor B-ALL or B-cell lymphoblastic lymphoma who had received at least one first-line and one salvage regimen of chemotherapy or a prior allogeneic hematopoietic stem cell transplant (HSCT).
Administration Dosage
40 ug/kg administered over 30 minutes every other day with six total doses per 21-day cycle.
Related Clinical Trial
NCT Number NCT02227108  Clinical Status Phase 2
Clinical Description
A phase 2, multicenter, single-arm study of moxetumomab pasudotox in pediatric subjects with relapsed or refractory pediatric acute lymphoblastic leukemia (pALL) or lymphoblastic lymphoma of B-cell origin.
Primary Endpoint
This phase 2 study was terminated at interim analysis for a CR rate that did not reach the stage 1 target. 3 of 28 evaluable patients (10.71%) attained CR none of whom were MRD negative.
Other Endpoint
Ten patients (33.33%) experienced at least 1 treatment-related serious adverse event, including capillary leak syndrome (CLS; n=6), hemolytic uremic syndrome (HUS; n=4).
Experiment 7 Reporting the Activity Date of This ADC [7]
Patients Enrolled
Multiply relapsed or chemotherapy-refractory ALL who had received 1 standard and 1 salvage regimen or allogeneic stem-cell transplant were eligible. Bone marrow involvement with 5% blasts was required, with blasts being CD22+ (ie, 30% of blasts expressing CD22 by flow cytometry).
Administration Dosage
5 to 50 ug/kg was administered via IV infusion over 30 minutes every other day in a 21-day cycle.
Related Clinical Trial
NCT Number NCT00659425  Clinical Status Phase 1
Clinical Description
A phase 1, multicenter, dose escalation study of CAT-8015 in children, adolescents and young adults with refractory CD22+ acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL).
References
Ref 1 Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018 Aug;32(8):1768-1777.
Ref 2 Moxetumomab pasudotox in heavily pre-treated patients with relapsed/refractory hairy cell leukemia (HCL): long-term follow-up from the pivotal trial. J Hematol Oncol. 2021 Feb 24;14(1):35.
Ref 3 A phase I study of moxetumomab pasudotox in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia. Br J Haematol. 2018 Aug;182(3):442-444.
Ref 4 Minimal residual hairy cell leukemia eradication with moxetumomab pasudotox: phase 1 results and long-term follow-up. Blood. 2018 May 24;131(21):2331-2334.
Ref 5 Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia. J Clin Oncol. 2012 May 20;30(15):1822-8.
Ref 6 Results from an international phase 2 study of the anti-CD22 immunotoxin moxetumomab pasudotox in relapsed or refractory childhood B-lineage acute lymphoblastic leukemia. Pediatr Blood Cancer. 2020 May;67(5):e28112.
Ref 7 Phase 1 study of the anti-CD22 immunotoxin moxetumomab pasudotox for childhood acute lymphoblastic leukemia. Blood. 2017 Oct 5;130(14):1620-1627.

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