Trial Outcomes & Findings for Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL) (NCT NCT01030536)

NCT ID: NCT01030536

Last Updated: 2018-04-09

Results Overview

MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity \[DLT\]) in more than 30 percent (%) of participants.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Day 1 to end of Cycle 1 (approximately 28 days)
• Results posted on: 2018-04-09

Participant Flow

Study was started on 15 Feb 2010 and was terminated on 12 Sep 2012. The Product Development Team authorized early termination of this study due to prioritization of resources and the need to prioritize allocation of investigational product across the studies in the moxetumomab pasudotox clinical development program.

A total of 30 participants were screened and enrolled, of them 7 were failed screening. Twenty three participants were enrolled and assigned to treatment at 6 sites in the United States.

Participant milestones

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Overall Study STARTED	7	6	6	3	1
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	7	6	6	3	1

Reasons for withdrawal

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Overall Study Withdrawal by Subject	0	0	1	0	0
Overall Study undefined	1	0	1	1	0
Overall Study Adverse Event	0	3	1	0	1
Overall Study Progressive disease	6	2	3	2	0
Overall Study Death	0	1	0	0	0

Baseline Characteristics

Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL)

Baseline characteristics by cohort

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Total n=23 Participants Total of all reporting groups
Age, Continuous Age	63.4 years STANDARD_DEVIATION 8.7 • n=5 Participants	53.7 years STANDARD_DEVIATION 16.9 • n=7 Participants	63.5 years STANDARD_DEVIATION 10.0 • n=5 Participants	52.3 years STANDARD_DEVIATION 14.6 • n=4 Participants	66.0 years STANDARD_DEVIATION NA • n=21 Participants	59.6 years STANDARD_DEVIATION 12.4 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	19 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 to end of Cycle 1 (approximately 28 days)

Population: Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.

MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity [DLT]) in more than 30 percent (%) of participants.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Maximum Tolerated Dose (MTD)	NA mcg/Kg Data was not reported as MTD was not reached in the specified arm group.	NA mcg/Kg Data was not reported as MTD was not reached in the specified arm group.	NA mcg/Kg Data was not reported as MTD was not reached in the specified arm group.	NA mcg/Kg Data was not reported as MTD was not reached in the specified arm group.	NA mcg/Kg Data was not reported as MTD was not reached in the specified arm group.

PRIMARY outcome

Timeframe: Day 1 to end of Cycle 1 (approximately 28 days)

Population: Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.

Any Grade 3 or greater, non-hematological toxicity (including capillary leak syndrome [CLS] and thrombotic microangiopathy/ hemolytic uremic syndrome (HUS), Grade 3 or higher treatment-related hematologic toxicities and only ≥ Grade 3 thrombotic microangiopathy /HUS constituted a DLT with few exceptions.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Screening (Day -28) to Post Therapy Day 30

Population: Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TEAEs	7 Participants	6 Participants	6 Participants	3 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) TESAEs	0 Participants	3 Participants	2 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Screening (Day -28) to Post Therapy Day 30

Population: Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Anaemia	0 Participants	3 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Neutrophil count decreased	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Neutropenia	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Platelet count decreased	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Thrombocytopenia	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Leukocytosis	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypoalbuminaemia	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypertriglyceridaemia	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hyponatraemia	0 Participants	1 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Alanine aminotransferase increased	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Blood creatinine increased	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypernatraemia	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypocalcaemia	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Aspartate aminotransferase increased	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypokalaemia	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Blood alkaline phosphatase increased	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypercalcaemia	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hyperglycaemia	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hyperkalaemia	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hyperuricaemia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypophosphataemia	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Blood albumin decreased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Blood bicarbonate increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Blood bilirubin increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Blood triglycerides increased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Haptoglobin decreased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hyperchlorhydria	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hyperlipidaemia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypermagnesaemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hematuria	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Screening (Day -28) to Post Therapy Day 30

Population: Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypotension	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Hypertension	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Pyrexia	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Weight Increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Screening (Day -28) to Post Therapy Day 30

Population: Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Sinus Tachycardia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) ECG QT Prolonged	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

The CR rate was defined as the percentage of participants who had achieved CR based on both the evaluable population for efficacy.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Percentage of Participants With Complete Response (CR)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

Duration of CR was measured from the first documentation of a CR to the time of relapse for the subgroup of participants with CR. Duration of CR was calculated using the Kaplan Meier method. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Duration of Complete Response	NA Months No participants had complete response over the study period, so duration of complete response could not be assessed.	NA Months No participants had complete response over the study period, so duration of complete response could not be assessed.	NA Months No participants had complete response over the study period, so duration of complete response could not be assessed.	NA Months No participants had complete response over the study period, so duration of complete response could not be assessed.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Percentage of Participants With Partial Response (PR)	10 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

OR was defined as the percentage of participants with CR or partial response (PR).

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Percentage of Participants With Objective Response (OR)	10 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

TTR was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was only assessed in participants who had achieved objective response (OR).

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Time to Response (TTR)	0.79 Months Interval 0.79 to 0.79	NA Months No participants had partial or complete response, so time to response could not be assessed.	NA Months No participants had partial or complete response, so time to response could not be assessed.	NA Months No participants had partial or complete response, so time to response could not be assessed.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

DOR was measured from the first documentation of OR to the event of relapse. DOR was calculated using the Kaplan-Meier method.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Duration of Objective Response (DOR)	7.66 Months Interval 7.66 to 7.66	NA Months No participants had partial or complete response, so duration of objective response could not be assessed.	NA Months No participants had partial or complete response, so duration of objective response could not be assessed.	NA Months No participants had partial or complete response, so duration of objective response could not be assessed.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

Duration of SD was defined as the time period from start of moxetumomab pasudotox administration to the event of progressive disease (PD)/relapse. Duration of SD was only calculated for the subgroup of participants with best response of CR, PR, or SD, and was calculated using the Kaplan-Meier method.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Duration of Stable Disease (SD)	1.87 Months Interval 0.79 to 8.41	NA Months No participants had objective response (either complete or partial response) or stable disease, so duration of stable disease could not be assessed.	0.95 Months Interval 0.95 to 0.95	4.67 Months Interval 3.71 to 5.62	—

SECONDARY outcome

Timeframe: Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Maximum observed drug concentration of Moxetumomab pasudotox in plasma.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox	283 nanogram per milliliter (ng/mL) Standard Deviation 159	452 nanogram per milliliter (ng/mL) Standard Deviation 141	589 nanogram per milliliter (ng/mL) Standard Deviation 366	769 nanogram per milliliter (ng/mL) Standard Deviation 221	818 nanogram per milliliter (ng/mL) Standard Deviation NA Standard Deviation was not calculated as only one participant was evaluated

SECONDARY outcome

Timeframe: Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Area under the concentration versus time curve from zero to infinity (AUC) of Moxetumomab pasudotox in Plasma.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox	1120 hour*nanogram per milliliter (hr*ng/mL) Standard Deviation 928	1640 hour*nanogram per milliliter (hr*ng/mL) Standard Deviation 682	2050 hour*nanogram per milliliter (hr*ng/mL) Standard Deviation 1150	2320 hour*nanogram per milliliter (hr*ng/mL) Standard Deviation 1010	1810 hour*nanogram per milliliter (hr*ng/mL) Standard Deviation NA Standard Deviation was not calculated as only one participant was evaluated

SECONDARY outcome

Timeframe: Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

CL of drug is rate at which drug is metabolized or eliminated by normal biological processes and is influenced by fraction of dose absorbed.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Clearance (CL) of Moxetumomab Pasudotox	31.6 milliliter per hour per kilogram Standard Deviation 25.5	22.2 milliliter per hour per kilogram Standard Deviation 12.5	26.9 milliliter per hour per kilogram Standard Deviation 18.6	25.2 milliliter per hour per kilogram Standard Deviation 12.9	33.1 milliliter per hour per kilogram Standard Deviation NA Standard Deviation was not calculated as only one participant was evaluated

SECONDARY outcome

Timeframe: Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Plasma decay half life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=5 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Elimination Half Life (t1/2) of Moxetumomab Pasudotox	1.55 hour Standard Deviation 1.10	1.87 hour Standard Deviation 0.985	1.68 hour Standard Deviation 0.726	1.87 hour Standard Deviation 0.586	0.901 hour Standard Deviation NA Standard Deviation was not calculated as only one participant was evaluated

SECONDARY outcome

Timeframe: Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)

Population: Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

The moxetumomab pasudotox specific bridging assay using the Meso Scale Discovery platform was employed to detect anti-drug antibodies (ADA).

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Participants With Positive Anti-Drug Antibody	5 Participants	4 Participants	5 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)

Population: Evaluable population for expression of CD22 on malignant cells included all participants with peripheral blood samples containing 10 or more B cells (CD19-positive cells) per cubic millimeter.

CD22 Expression was analyzed using Prism® analysis. Flow cytometry was performed to quantitate the CD22 expression for the purpose of evaluating the relationship of CD22 expression with response to treatment.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=2 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=4 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Participants With CD22 Expression Levels	8 Participants	5 Participants	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: From Screening (Day -28) to Post Therapy Day 30

Population: Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

The correlation of CLS and weight changes, albumin, hypotension, edema, hypoxia, and pulmonary AEs were examined.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs)	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Population: Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Outcome measures

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=10 Participants Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 Participants Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=1 Participants Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 Participants Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Percentage of Participants With Stable Disease (SD)	40.0 Percentage of Participants	0.0 Percentage of Participants	100.0 Percentage of Participants	66.7 Percentage of Participants	—

Adverse Events

CAT-8015 20 Microgram Per Kilogram (mcg/kg)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

CAT-8015 30 Microgram Per Kilogram (mcg/kg)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

CAT-8015 40 Microgram Per Kilogram (mcg/kg)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

CAT-8015 50 Microgram Per Kilogram (mcg/kg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CAT-8015 60 Microgram Per Kilogram (mcg/kg)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 participants at risk Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 participants at risk Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 participants at risk Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 participants at risk Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 participants at risk Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Infections and infestations Lung infection	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Blood creatinine increased	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Renal and urinary disorders Renal failure acute	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Vascular disorders Capillary leak syndrome	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30

Other adverse events

Measure	CAT-8015 20 Microgram Per Kilogram (mcg/kg) n=7 participants at risk Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 30 Microgram Per Kilogram (mcg/kg) n=6 participants at risk Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 40 Microgram Per Kilogram (mcg/kg) n=6 participants at risk Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 50 Microgram Per Kilogram (mcg/kg) n=3 participants at risk Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	CAT-8015 60 Microgram Per Kilogram (mcg/kg) n=1 participants at risk Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Vascular disorders Hypotension	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	50.0% 3/6 • Number of events 6 • From Screening (Day -28) to Post Therapy Day 30	50.0% 3/6 • Number of events 4 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Blood and lymphatic system disorders Neutropenia	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 5 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Eye disorders Vision blurred	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Gastrointestinal disorders Constipation	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	50.0% 3/6 • Number of events 4 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Gastrointestinal disorders Flatulence	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 3 • From Screening (Day -28) to Post Therapy Day 30	66.7% 2/3 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Gastrointestinal disorders Vomiting	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 3 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
General disorders Chills	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
General disorders Face oedema	28.6% 2/7 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
General disorders Fatigue	71.4% 5/7 • Number of events 6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	66.7% 4/6 • Number of events 4 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
General disorders Oedema peripheral	57.1% 4/7 • Number of events 5 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	50.0% 3/6 • Number of events 11 • From Screening (Day -28) to Post Therapy Day 30	66.7% 2/3 • Number of events 3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
General disorders Pain	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
General disorders Pyrexia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Infections and infestations Urinary tract infection	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Blood alkaline phosphatase increased	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Blood creatinine increased	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 8 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Electrocardiogram qt prolonged	28.6% 2/7 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Neutrophil count decreased	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Investigations Platelet count decreased	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Decreased appetite	28.6% 2/7 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hypernatraemia	28.6% 2/7 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	50.0% 3/6 • Number of events 9 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hyperuricaemia	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hypoalbuminaemia	28.6% 2/7 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	50.0% 3/6 • Number of events 3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 4 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	66.7% 2/3 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Psychiatric disorders Insomnia	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Renal and urinary disorders Haematuria	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 5 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	100.0% 1/1 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	50.0% 3/6 • Number of events 4 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	33.3% 1/3 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Vascular disorders Capillary leak syndrome	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Vascular disorders Haematoma	14.3% 1/7 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/6 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30
Vascular disorders Hypertension	0.00% 0/7 • From Screening (Day -28) to Post Therapy Day 30	33.3% 2/6 • Number of events 2 • From Screening (Day -28) to Post Therapy Day 30	16.7% 1/6 • Number of events 1 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/3 • From Screening (Day -28) to Post Therapy Day 30	0.00% 0/1 • From Screening (Day -28) to Post Therapy Day 30

Additional Information

Edward Bradley, MD

MedImmune LLC, Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom

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Results disclosure agreements

• Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER