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.
Cancer (Oncology), Cancer (Oncology) - Leukemia, Cancer (Oncology) - Lymphoma
Krish Patel, MD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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 antibodies
  • Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy)
  • Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit
(206) 215-3086