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

NCT01030536 — Phase 1 / Phase 2, Completed, 23 participants, MedImmune LLC
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Phase 1/2 Study of CAT-8015 in Adult Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

RegistryNCT01030536
StatusCompleted
PhasePhase 1 / Phase 2
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment23 (Actual)
SponsorMedImmune LLC (Industry)
ConditionsNon-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
InterventionsCAT-8015 20 mcg/kg, CAT-8015 30 mcg/kg, CAT-8015 40 mcg/kg, CAT-8015 50 mcg/kg, CAT-8015 60 mcg/kg (Drug)
Datesstart 2010-02-15, primary completion 2013-03-04, completion 2013-03-04, first posted 2009-12-11, last updated 2018-04-09
Locations8 sites in United States, Poland

Related Papers Related Patents Related Grants Related Experts
All trials for Non-Hodgkin Lymphoma All trials for Chronic Lymphocytic Leukemia All trials of CAT-8015 20 mcg/kg All trials of CAT-8015 30 mcg/kg

-Summary

The primary objectives of this study are to determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], mantle cell lymphoma \[MCL\]) or CLL.

Expand all sections  ·  Collapse all

+Detailed description

To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (DLBCL, FL, MCL) or CLL.

+Arms and interventions

ArmTypeInterventionsDescription
CAT-8015 20 microgram per kilogram (mcg/kg)ExperimentalDrug: CAT-8015 20 mcg/kgParticipants will receive 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 is 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 are possible if an MTD or OBD is not reached by 60 mcg/kg.
CAT-8015 30 mcg/kgExperimentalDrug: CAT-8015 30 mcg/kgParticipants will receive 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 is 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 are possible if an MTD or OBD is not reached by 60 mcg/kg.
CAT-8015 40 mcg/kgExperimentalDrug: CAT-8015 40 mcg/kgParticipants will receive 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 is 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 are possible if an MTD or OBD is not reached by 60 mcg/kg.
CAT-8015 50 mcg/kgExperimentalDrug: CAT-8015 50 mcg/kgParticipants will receive 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 is 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 are possible if an MTD or OBD is not reached by 60 mcg/kg.
CAT-8015 60 mcg/kgExperimentalDrug: CAT-8015 60 mcg/kgParticipants will receive 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 is 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 are possible if an MTD or OBD is not reached by 60 mcg/kg.
  • CAT-8015 20 mcg/kg (Drug): Participants will receive 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.
  • CAT-8015 30 mcg/kg (Drug): Participants will receive 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.
  • CAT-8015 40 mcg/kg (Drug): Participants will receive 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.
  • CAT-8015 50 mcg/kg (Drug): Participants will receive 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.
  • CAT-8015 60 mcg/kg (Drug): Participants will receive 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.

+Outcome measures

Primary outcomes

  • Maximum Tolerated Dose (MTD) [Day 1 to end of Cycle 1 (approximately 28 days)]: 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.
  • Number of Participants With Dose Limiting Toxicities (DLTs) [Day 1 to end of Cycle 1 (approximately 28 days)]: 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.
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [From Screening (Day -28) to Post Therapy Day 30]: 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.
  • Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From Screening (Day -28) to Post Therapy Day 30]: 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.
  • Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From Screening (Day -28) to Post Therapy Day 30]: 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.
  • Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From Screening (Day -28) to Post Therapy Day 30]: 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.

Secondary outcomes

  • Percentage of Participants With Complete Response (CR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]: The CR rate was defined as the percentage of participants who had achieved CR based on both the evaluable population for efficacy.
  • Duration of Complete Response [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]: 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.
  • Percentage of Participants With Partial Response (PR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]
  • Percentage of Participants With Objective Response (OR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]: OR was defined as the percentage of participants with CR or partial response (PR).
  • Time to Response (TTR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]: 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).
  • Duration of Objective Response (DOR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]: DOR was measured from the first documentation of OR to the event of relapse. DOR was calculated using the Kaplan-Meier method.
  • Duration of Stable Disease (SD) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]: 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.
  • Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox [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]: Maximum observed drug concentration of Moxetumomab pasudotox in plasma.
  • Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox [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]: Area under the concentration versus time curve from zero to infinity (AUC) of Moxetumomab pasudotox in Plasma.
  • Clearance (CL) of Moxetumomab Pasudotox [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]: CL of drug is rate at which drug is metabolized or eliminated by normal biological processes and is influenced by fraction of dose absorbed.
  • Elimination Half Life (t1/2) of Moxetumomab Pasudotox [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]: Plasma decay half life is the time measured for the plasma concentration to decrease by one half.
  • Number of Participants With Positive Anti-Drug Antibody [Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)]: The moxetumomab pasudotox specific bridging assay using the Meso Scale Discovery platform was employed to detect anti-drug antibodies (ADA).
  • Number of Participants With CD22 Expression Levels [Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)]: 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.
  • Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs) [From Screening (Day -28) to Post Therapy Day 30]: The correlation of CLS and weight changes, albumin, hypotension, edema, hypoxia, and pulmonary AEs were examined.
  • Percentage of Participants With Stable Disease (SD) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

+Eligibility

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

Inclusion Criteria:

* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Participants must have histologically confirmed B-cell CLL, including small lymphocytic lymphoma (SLL), DLBCL, MCL, or FL
* B-cell NHL: a) Have previous confirmation of B-cell NHL b) Participants with DLBCL or MCL, must have relapsed or refractory disease after at least one prior regimen containing rituximab, either alone or in combination, and be ineligible for any available standard line of therapy known to be life-prolonging or life-saving c) Participants with FL, must have relapsed or refractory disease after at least two prior regimens, one of which included rituximab, either alone or in combination, and be ineligible for any available standard line of therapy known to be life-prolonging or life-saving d) Have measurable disease (at least one lesion greater than or equal to (≥) 20 millimeter (mm) in one dimension or ≥ 15 mm in two dimensions as measured by conventional or high resolution \[spiral\] computed tomography e) Not be a candidate for a hematopoietic stem cell (HSC) or bone marrow transplant
* B-cell CLL: a) Have previous confirmation of B-cell CLL with a characteristic immunophenotype by flow cytometry b) Have relapsed or refractory disease after at least 2 prior lines of treatment, at least 1 of which must have contained rituximab and be ineligible for any available standard line of therapy known to be life-prolonging or life-saving c) Not be a candidate for an HSC or BM transplant d) Have symptomatic disease that requires treatment
* Karnofsky Performance Status ≥ 70
* Life expectancy of ≥ 12 weeks
* Toxicities from previous cancer therapies must have recovered to Grade less than (<) 2
* Adequate hematological function defined as: a) Hemoglobin ≥ 9 g/dL b) Absolute neutrophil count ≥ 1500/mm\^3 c) Platelet count ≥ 75,000/mm\^3
* Prothrombin time-International Normalized Ratio/Partial thromboplastin time less than or equal to (≤) 1.5 × upper limit of normal (ULN), or for participants on anticoagulation therapy, status within therapeutic range
* Women of non-child-bearing potential or using effective contraception
* Male participants with partners of child-bearing potential must be surgically sterile or use a contraceptive method

Exclusion Criteria:

* Any available standard line of therapy known to be life-prolonging or life-saving
* Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for treatment of cancer
* For CLL participants only, rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy
* History of allergy or reaction to any component of the CAT-8015
* Receipt of any chemotherapy or small molecule targeted therapy or any biological- or immunological-based therapies for leukemia or lymphoma within 6 weeks
* Prior radiation therapy will not be excluded, providing the volume of bone marrow treated is less than 25 percent
* Any history of prior pseudomonas-exotoxin immunotoxin administration including CAT-8015, CAT-3888, or LMB-2
* History of other invasive malignancy within 5 years, with some exceptions
* Evidence of significant active infection requiring antimicrobial, antifungal, antiparasitic or antiviral therapy or for which other supportive care is given
* Autologous stem cell transplantation within 6 months prior to study entry
* Allogenic stem cell transplantation or any other organ transplant
* HIV-positive or AIDS, Hepatitis B or hepatitis C infection as defined by seropositive for hepatitis B (HBsAg) or hepatitis C and elevated liver transaminases
* Use of immunosuppressive medication other than steroids within 7 days, use of systemic steroids within 7 days before the first dose of CAT-8015 (inhaled and topical corticosteroids are permitted). Participants may take replacement doses of steroids (defined as ≤ 30 mg/day hydrocortisone or the equivalent) if on a stable dose for at least 2 weeks prior to the first dose of CAT-8015
* Documented current central nervous system involvement by leukemia or lymphoma
* Pregnancy or lactation, other severe, concurrent diseases
* Concurrent enrollment in another clinical study

+Posted results

Participant flow

MilestoneCAT-8015 20 Microgram Per Kilogram (mcg/kg)CAT-8015 30 Microgram Per Kilogram (mcg/kg)CAT-8015 40 Microgram Per Kilogram (mcg/kg)CAT-8015 50 Microgram Per Kilogram (mcg/kg)CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Started76631
Completed00000
Not completed76631

Outcome results

  • Maximum Tolerated Dose (MTD) (Primary), Number, mcg/Kg: CAT-8015 20 Microgram Per Kilogram (mcg/kg) NA; CAT-8015 30 Microgram Per Kilogram (mcg/kg) NA; CAT-8015 40 Microgram Per Kilogram (mcg/kg) NA; CAT-8015 50 Microgram Per Kilogram (mcg/kg) NA; CAT-8015 60 Microgram Per Kilogram (mcg/kg) NA
  • Number of Participants With Dose Limiting Toxicities (DLTs) (Primary), Count of participants, Participants: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 2; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 1; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 1
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (Primary), Count of participants, Participants: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 7; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 6; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 6; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 3; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 1
  • Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) (Primary), Count of participants, Participants: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 3; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 3; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 1
  • Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) (Primary), Count of participants, Participants: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 1; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 1; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 1; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 1
  • Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) (Primary), Count of participants, Participants: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 1; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 0
  • Percentage of Participants With Complete Response (CR) (Secondary), Number, Percentage of Participants: Chronic Lymphocytic Leukemia 0; Diffuse Large B Cell Lymphoma 0; Mantle Cell Lymphoma 0; Follicular Lymphoma 0
  • Duration of Complete Response (Secondary), Median, Months: Chronic Lymphocytic Leukemia NA (NA to NA); Diffuse Large B Cell Lymphoma NA (NA to NA); Mantle Cell Lymphoma NA (NA to NA); Follicular Lymphoma NA (NA to NA)
  • Percentage of Participants With Partial Response (PR) (Secondary), Number, Percentage of Participants: Chronic Lymphocytic Leukemia 10; Diffuse Large B Cell Lymphoma 0; Mantle Cell Lymphoma 0; Follicular Lymphoma 0
  • Percentage of Participants With Objective Response (OR) (Secondary), Number, Percentage of Participants: Chronic Lymphocytic Leukemia 10; Diffuse Large B Cell Lymphoma 0; Mantle Cell Lymphoma 0; Follicular Lymphoma 0
  • Time to Response (TTR) (Secondary), Median, Months: Chronic Lymphocytic Leukemia 0.79 (0.79 to 0.79); Diffuse Large B Cell Lymphoma NA (NA to NA); Mantle Cell Lymphoma NA (NA to NA); Follicular Lymphoma NA (NA to NA)
  • Duration of Objective Response (DOR) (Secondary), Median, Months: Chronic Lymphocytic Leukemia 7.66 (7.66 to 7.66); Diffuse Large B Cell Lymphoma NA (NA to NA); Mantle Cell Lymphoma NA (NA to NA); Follicular Lymphoma NA (NA to NA)
  • Duration of Stable Disease (SD) (Secondary), Median, Months: Chronic Lymphocytic Leukemia 1.87 (0.79 to 8.41); Diffuse Large B Cell Lymphoma NA (NA to NA); Mantle Cell Lymphoma 0.95 (0.95 to 0.95); Follicular Lymphoma 4.67 (3.71 to 5.62)
  • Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox (Secondary), Mean, nanogram per milliliter (ng/mL): CAT-8015 20 Microgram Per Kilogram (mcg/kg) 283 +/- 159; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 452 +/- 141; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 589 +/- 366; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 769 +/- 221; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 818 +/- NA
  • Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox (Secondary), Mean, hour*nanogram per milliliter (hr*ng/mL): CAT-8015 20 Microgram Per Kilogram (mcg/kg) 1120 +/- 928; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 1640 +/- 682; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 2050 +/- 1150; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 2320 +/- 1010; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 1810 +/- NA
  • Clearance (CL) of Moxetumomab Pasudotox (Secondary), Mean, milliliter per hour per kilogram: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 31.6 +/- 25.5; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 22.2 +/- 12.5; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 26.9 +/- 18.6; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 25.2 +/- 12.9; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 33.1 +/- NA
  • Elimination Half Life (t1/2) of Moxetumomab Pasudotox (Secondary), Mean, hour: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 1.55 +/- 1.10; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 1.87 +/- 0.985; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 1.68 +/- 0.726; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 1.87 +/- 0.586; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 0.901 +/- NA
  • Number of Participants With Positive Anti-Drug Antibody (Secondary), Count of participants, Participants: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 5; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 4; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 5; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 2; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 0
  • Number of Participants With CD22 Expression Levels (Secondary), Count of participants, Participants: Chronic Lymphocytic Leukemia 8; Diffuse Large B Cell Lymphoma 5; Mantle Cell Lymphoma 2; Follicular Lymphoma 1
  • Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs) (Secondary), Count of participants, Participants: CAT-8015 20 Microgram Per Kilogram (mcg/kg) 1; CAT-8015 30 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 40 Microgram Per Kilogram (mcg/kg) 1; CAT-8015 50 Microgram Per Kilogram (mcg/kg) 0; CAT-8015 60 Microgram Per Kilogram (mcg/kg) 0
  • 1 more outcome measures not shown.

Adverse events

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

ArmDeathsSerious adverse eventsOther adverse events
CAT-8015 20 Microgram Per Kilogram (mcg/kg)00/7 (0.0%)7/7 (100.0%)
CAT-8015 30 Microgram Per Kilogram (mcg/kg)03/6 (50.0%)6/6 (100.0%)
CAT-8015 40 Microgram Per Kilogram (mcg/kg)02/6 (33.3%)6/6 (100.0%)
CAT-8015 50 Microgram Per Kilogram (mcg/kg)00/3 (0.0%)3/3 (100.0%)
CAT-8015 60 Microgram Per Kilogram (mcg/kg)01/1 (100.0%)1/1 (100.0%)

Serious adverse events by term

TermOrgan systemCAT-8015 20 Microgram Per Kilogram (mcg/kg)CAT-8015 30 Microgram Per Kilogram (mcg/kg)CAT-8015 40 Microgram Per Kilogram (mcg/kg)CAT-8015 50 Microgram Per Kilogram (mcg/kg)CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Lung infectionInfections and infestations0/70/61/60/30/1
Blood creatinine increasedInvestigations0/70/60/60/31/1
Diffuse large b-cell lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/71/60/60/30/1
Tumour associated feverNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/71/60/60/30/1
Renal failure acuteRenal and urinary disorders0/70/60/60/31/1
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders0/71/60/60/30/1
Capillary leak syndromeVascular disorders0/70/61/60/30/1

Other adverse events by term

TermOrgan systemCAT-8015 20 Microgram Per Kilogram (mcg/kg)CAT-8015 30 Microgram Per Kilogram (mcg/kg)CAT-8015 40 Microgram Per Kilogram (mcg/kg)CAT-8015 50 Microgram Per Kilogram (mcg/kg)CAT-8015 60 Microgram Per Kilogram (mcg/kg)
AnaemiaBlood and lymphatic system disorders0/73/63/60/31/1
NeutropeniaBlood and lymphatic system disorders1/71/60/60/30/1
ThrombocytopeniaBlood and lymphatic system disorders0/72/60/60/30/1
Vision blurredEye disorders1/70/60/60/31/1
Abdominal painGastrointestinal disorders0/71/61/61/30/1
ConstipationGastrointestinal disorders0/71/62/61/31/1
DiarrhoeaGastrointestinal disorders1/70/63/60/30/1
DyspepsiaGastrointestinal disorders0/70/61/61/30/1
FlatulenceGastrointestinal disorders0/71/61/60/30/1
NauseaGastrointestinal disorders2/70/62/62/30/1
VomitingGastrointestinal disorders0/71/62/61/30/1
ChillsGeneral disorders0/71/61/60/30/1
Face oedemaGeneral disorders2/71/60/61/31/1
FatigueGeneral disorders5/70/64/60/30/1
Oedema peripheralGeneral disorders4/71/63/62/31/1
PainGeneral disorders0/71/60/60/31/1
PyrexiaGeneral disorders0/71/61/60/30/1
Urinary tract infectionInfections and infestations0/71/61/60/30/1
Alanine aminotransferase increasedInvestigations1/71/60/61/31/1
Aspartate aminotransferase increasedInvestigations1/71/60/61/30/1
Blood alkaline phosphatase increasedInvestigations0/70/60/61/31/1
Blood creatinine increasedInvestigations1/72/60/60/30/1
Electrocardiogram qt prolongedInvestigations2/70/60/60/30/1
Neutrophil count decreasedInvestigations1/70/60/61/31/1
Platelet count decreasedInvestigations0/70/61/60/31/1
Decreased appetiteMetabolism and nutrition disorders2/70/60/60/30/1
HypercalcaemiaMetabolism and nutrition disorders0/71/60/60/31/1
HyperglycaemiaMetabolism and nutrition disorders0/71/61/60/30/1
HyperkalaemiaMetabolism and nutrition disorders0/71/61/60/30/1
HypernatraemiaMetabolism and nutrition disorders2/70/61/60/31/1
HypertriglyceridaemiaMetabolism and nutrition disorders0/73/60/61/31/1
HyperuricaemiaMetabolism and nutrition disorders1/70/60/60/31/1
HypoalbuminaemiaMetabolism and nutrition disorders2/71/62/60/31/1
HypocalcaemiaMetabolism and nutrition disorders0/71/62/60/31/1
HypokalaemiaMetabolism and nutrition disorders0/70/61/61/31/1
HyponatraemiaMetabolism and nutrition disorders0/71/63/60/31/1
HypophosphataemiaMetabolism and nutrition disorders0/70/61/61/30/1
Back painMusculoskeletal and connective tissue disorders1/72/60/60/30/1
Musculoskeletal chest painMusculoskeletal and connective tissue disorders0/71/61/61/30/1
MyalgiaMusculoskeletal and connective tissue disorders1/70/61/61/30/1
Pain in extremityMusculoskeletal and connective tissue disorders0/70/61/61/30/1
DizzinessNervous system disorders1/71/62/61/30/1
HeadacheNervous system disorders1/72/61/62/31/1
InsomniaPsychiatric disorders0/72/60/60/30/1
HaematuriaRenal and urinary disorders0/71/61/60/31/1
CoughRespiratory, thoracic and mediastinal disorders1/70/63/60/30/1
DyspnoeaRespiratory, thoracic and mediastinal disorders0/71/62/61/30/1
Capillary leak syndromeVascular disorders1/70/61/60/30/1
HaematomaVascular disorders1/70/61/60/30/1
HypertensionVascular disorders0/72/61/60/30/1
HypotensionVascular disorders1/71/61/60/31/1

+Locations (8)

FacilityCityCountryStatus
Research SiteLos Angeles, CaliforniaUnited States
Research SiteIndianapolis, IndianaUnited States
Research SiteBethesda, MarylandUnited States
Research SiteLas Vegas, NevadaUnited States
Research SiteCharleston, South CarolinaUnited States
Research SiteNashville, TennesseeUnited States
Research SiteTemple, TexasUnited States
Research SiteLodzPoland

+Investigators