SHS_492348 PATK CXNC 16182

A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 in Patients With CD20-Expressing Hematologic Malignancies

This study will determine a dose and schedule for XmAb13676 in the treatment of 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 study entry
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
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 sytem 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 compormise
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
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 antibodies
Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy)
Phase I
Krish Patel, M.D.
Tenzin Tsomo
  • Swedish Medical Center