18 and older, any sex, with Leukemia, Lymphoma, Chronic Lymphocytic or Leukemia, Prolymphocytic Leukemia, Small. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Primary· From start of study drug administration until 30 days after the last dose of study drug
An adverse event (AE) events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offs
TEAEs
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
3
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
3
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
5
TESAEs
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
2
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
3
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)Primary· From start of study drug administration until 30 days after the last dose of study drug
The vital sign abnormalities which require an action or intervention by the investigator, or a finding judged by the investigator were reported as an adverse event. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.
Pyrexia
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
± 0.56
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
± 0.70
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
1
± 0.29
Sinus tachycardia
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)Primary· From start of study drug administration until 30 days after the last dose of study drug
AEs observed in participants with clinically significant ECG abnormalities were assessed.
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)Primary· From start of study drug administration until 30 days after the last dose of study drug
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.
Hemoglobin decreased
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
3
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
1
Platelet count decreased
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
2
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
1
Neutrophil count decreased
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
2
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Lymphocyte count decreased
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
White blood cell count decreased
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Neutropenia
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Febrile neutropenia
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Blood albumin decreased
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
2
Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)Primary· Up to 2 years of post-treatment follow-up
Objective response rate defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria.
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Best Overall Objective Tumor ResponsePrimary· Up to 2 years of post-treatment follow-up
Antitumor activity was assessed by best overall objective tumor response.
Complete response (CR)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Partial Response (PR)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0
Stable Disease (SD)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
2
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
3
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
2
Progressive Disease (PD)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
3
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab PasudotoxPrimary· Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3
The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.
Cycle 1, Day 1 (n=3,3,5)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0.500
0.500 – 0.500
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0.50
0.500 – 0.500
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0.500
0.00 – 0.500
Cycle 1, Day 5 (n=3,3,5)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0.500
0.500 – 0.500
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0.500
0.300 – 0.500
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0.500
0.300 – 1.00
Cycle 2, Day 1 (n=2,2,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
4.25
0.500 – 8.00
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0.375
0.250 – 0.500
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0.500
0.500 – 0.500
Cycle 2, Day 5 (n=2,2,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0.500
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0.800
0.500 – 1.00
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0.500
0.500 – 0.500
Cycle 3, Day 1 (n=1,1,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0.500
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0.500
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0.500
0.500 – 0.500
Cycle 3, Day 5 (n=1,1,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0.500
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
2.00
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
0.500
0.500 – 0.500
Cycle 4, Day 1 (n=1,NA,NA)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0.500
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
Cycle 4, Day 5 (n=1,NA,NA)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0.500
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
Maximum Observed Serum Concentration (Cmax) for Moxetumomab PasudotoxPrimary· Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3
The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
Cycle 1, Day 1 (n=3,3,5)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
97
59.1 – 107
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
57.7
46.5 – 145
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
180
63.7 – 351
Cycle 1, Day 5 (n=3,3,5)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
80.9
56.4 – 122
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
117
44.7 – 166
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
206
108 – 353
Cycle 2, Day 1 (n=2,2,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
94.0
66.0 – 122
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
723
146 – 1300
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
156
134 – 178
Cycle 2, Day 5 (n=2,2,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
50.5
0.00 – 101
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
80.8
72.3 – 89.2
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
211
171 – 250
Cycle 3, Day 1 (n=1,1,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
107
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
154
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
160
63.9 – 257
Cycle 3, Day 5 (n=1,1,2)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
93.4
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
200
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
266
156 – 376
Cycle 4, Day 1 (n=1,NA,NA)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
84.9
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
Cycle 4, Day 5 (n=1,NA,NA)
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
86.2
NA – NA
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
NA
NA – NA
Number of Participants With Positive Neutralizing AntibodiesSecondary· Up to end of treatment (4-6 weeks after the last dose)
Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (\>)50 pe
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
0
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
1
Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) ExpressionSecondary· End of treatment (4-6 weeks after the last dose)
Participants demonstrated CD22 expression on malignant cells at Screening and CD22 is a regulatory molecule that prevents the over activation of the immune system and the development of autoimmune diseases.
CD22-PE [OF CD5+/CD19+]
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
-33.65
± 27.79
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
-10.25
± 16.05
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
-8.85
± 16.19
(MESF CD22-PE [of CD5+/CD19+])
Group
Value
95% CI
CAT-8015 5 Microgram Per Kilogram (mcg/kg)
1139
± 1514.6
CAT-8015 10 Microgram Per Kilogram (mcg/kg)
-3076
± 5982.1
CAT-8015 20 Microgram Per Kilogram (mcg/kg)
-342.8
± 1816.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study drug administration until 30 days after the last dose of study drug.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic Lymphoma (SLL).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedImmune LLC
Last refreshed: 6 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00587457.