The Safety, Pharmacokinetic and Pharmacodynamic Effect of KA2237 (PI3 Kinase p110β/δ Inhibitor) In B Cell Lymphoma

An Open Label Ascending Dose Study Evaluating the Safety/Tolerability, Pharmacokinetic and Pharmacodynamic Effects of KA2237 In Patients With B Cell Lymphoma

NCT02679196•Karus Therapeutics Limited

View on ClinicalTrials.gov

Summary

Multiple ascending dose study to evaluate safety/tolerability, pharmacokinetic and pharmacodynamics effects of KA2237 (PI3 Kinase p110β/δ Inhibitor) in patients with B Cell Lymphoma and determine the maximum tolerated dose (MTD) in Part I of the study. In Part II, patients with B cell lymphoma will be treated with KA2237 at the MTD to evaluate safety and efficacy in the patient population.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years at the screening visit.
•2. Has given written consent to participate in the study.
•3. Has B-cell lymphoma refractory to or intolerant of established therapy known to provide clinical benefit for their condition and having received rituximab as a single agent or in combination with other therapies.
•4. Disease status requirement: Measurable disease defined as the presence of ≥ 1 nodal lesion that measures ≥ 1.5 cm in a single dimension as assessed by X-ray Computed Tomography (CT) (Positron Emission Tomography (PET/CT), or magnetic resonance imaging \[MRI\]
•5. Eastern Co-operative Oncology Group (ECOG) performance status of ≤ 2.
•6. For men and women of child-bearing potential, willing to use adequate contraception

Exclusion Criteria

•1. Subject is a chronic alcoholic (intake \> 35 units of alcohol (\>5 bottles of wine weekly)) or drug abuser
•2. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, may compromise the subject's ability to participate in this study
•3. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following the last dose of investigational product
•4. Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal disease (estimated glomerular filtration rate (eGFR) \<30ml/min), hepatic (Alanine transaminase (ALT) 2.5 times upper limit of normal (\>2.5xULN), bilirubin \> 2x ULN), hematological (absolute neutrophil count (ANC) \<1.0 x 109/L, platelet count \<75x109/L or requires regular platelet transfusions to maintain a platelet count ≥ 75 x 109/L , hemoglobin \<9g/dL), endocrine (glycated Haemoglobin (HbA1c)\>7% or random glucose \>200mg/dL), pulmonary (Forced Expiratory Volume in 1 second (FEV1) \<70% of predicted value), cardiac (New York Heart Association (NYHA)) class III/IV, or neurological disease
•5. Has had an allogeneic stem cell transplant with current active graft-versus-host-disease.
•6. Has known active central nervous system involvement of the malignancy.
•7. Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.
•8. Has a positive test for human immunodeficiency virus (HIV) antibodies.
•9. Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible.
•10. Disease-related exclusions
+9 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

July 1, 2016

Primary Completion Date

December 24, 2018

Completion Date

December 24, 2018

Last Updated

February 6, 2019

Enrollment

ACTUAL participants

Conditions

Lymphoma, B Cell

Interventions

KA2237

DRUG

Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma

NCT02992834

Lymphoma, B Cell

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COMPLETEDPHASE2

Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

NCT00210379

Lymphoma, B Cell

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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