Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies

Inclusion Criteria

• Able to provide written informed consent
• Diagnosis of either Non-CLL B cell malignancy or CLL/SLL
• Ineligible for or have exhausted standard therapeutic options
• Last dose of anti-CD20 antibody therapy must have been >4 weeks before the first dose of XmAb13676
• ECOG performance status 0-2
• Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
• Fertile patients must agree to use effective contraception during and for 4 weeks after completion of study
• Able and willing to complete the entire study

Exclusion Criteria

• Cytotoxic chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or small molecule or investigational agents within 6 elimination half-lives of the first dose of XmAb13676
• Prior allogeneic stem cell or solid organ transplantation
• Failure to recover from Grade 3 or 4 toxicity from previous treatment
• Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
• Known intolerance to CD20 monoclonal antibody therapy
• History of primary central nervous system lymphoma or neoplastic central nervous system disease
• Platelet count < 50 x 10^9/L
• Absolute neutrophil count < 1.0 x 10^9/L
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at screening > 3x upper limit of normal (ULN)
• Bilirubin > 1.5 mg/dL
• Estimated creatinine clearance < 50 mL/min
• Active/uncontrolled autoimmune disease
• Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
• Seizure disorder
• History of stroke with the past year
• History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
• Evidence of any serious bacterial, viral, parasitic or systemic fungal infections within the 30 days prior to study entry
• Positive test for human immunodeficiency virus (HIV) or hepatitis C (HCV) antibodies (unless HCV viral load test by PCR is negative)
• Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy). HBcAb positivity will be allowed if HBsAb is present.
• Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Xencor, Inc.

• Primary ID XmAb13676-01
• Secondary IDs NCI-2016-01843
• Clinicaltrials.gov ID NCT02924402