for people ages 18 years and up (full criteria)
study started
estimated completion



The purpose of this study is to determine the safety and tolerability of intravenous (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).

Official Title

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


B-cell Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia NHL B-cell Prolymphocytic Leukemia Transformed Lymphoma Burkitt's Lymphoma Mantle Cell Lymphoma Hairy Cell Leukemia Splenic Marginal Zone Lymphoma Waldenstrom's Macroglobulinemia Variant Hairy Cell Leukemia Splenic B-cell Lymphoma/Leukemia Lymphoplasmacytic Lymphoma Extranodal Marginal Zone Lymphoma (MALT) MALT Lymphoma Nodal Marginal Zone Lymphoma Follicular Lymphoma In Situ Follicular Neoplasia Duodenal-type Follicular Lymphoma Large B-cell Lymphoma with IRF4 rearrangement Primary Cutaneous Follicle Center Lymphoma Diffuse Large B-cell Lymphoma DLBCL T-cell/Histiocyte-Rich Large B-cell Lymphoma Primary Cutaneous DLBCL, leg type EBV-positive DLBCL, NOS EBV-positive Mucocutaneous Ulcer DLBCL Associated with Chronic Inflammation Lymphomatoid Granulomatosis Primary Mediastinal (Thymic) Large B-cell Lymphoma Intravascular Large B-cell Lymphoma ALK+ Large B-cell Lymphoma Plasmablastic Lymphoma Primary Effusion Lymphoma HHV8+ DLBCL Burkitt-like Lymphoma with 11q Aberration High-grade B-cell Lymphoma B-cell Lymphoma, unclassifiable Post-transplant Lymphoproliferative Disorder PTLD CLL SLL High-grade Lymphoma Richter's Transformation Lymphoma Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Hematologic Neoplasms Lymphoma, B-Cell XmAb13676


You can join if…

Open to people ages 18 years and up

  • 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 and have relapsed or refractory disease
  • ECOG performance status 0-2
  • Fertile patients must agree to use highly effective contraception during and for 5 months (male patients) and 8 months (female patients) after last dose of XmAb13676
  • Able and willing to complete the entire study

Additional Patient Inclusion Criteria for the DLBCL Cohort (Expansion Phase)

  1. Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
  2. Patient must be refractory or have relapsed after 2 or more standard therapeutic options, at least one of which must have included anti-CD20 antibody therapy.
  3. Not a candidate for or refusing treatment with hematopoietic stem cell transplantation

Additional Patient Inclusion Criteria for the Follicular Lymphoma Cohort (Expansion Phase)

  1. Diagnosis of follicular lymphoma Grades 1-3a
  2. Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.

You CAN'T join if...

  • Cytotoxic chemotherapy, radiotherapy, or immunotherapy including other anti-CD20 antibodies 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 109/L

  • Absolute neutrophil count < 1.0 x 109/L

  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at screening > 3x upper limit of normal (ULN)
  • Bilirubin > 1.5 mg/dL unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)
  • Estimated creatinine clearance < 50 40 mL/min
  • Active/uncontrolled autoimmune disease
  • Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
  • Seizure disorder
  • History of stroke with the past year6 mos prior to study entry
  • 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, and 8 months after the last dose of study drug
  • Positive urine pregnancy test (ie, urine human chorionic gonadotropin) at screening
  • Live viral vaccine within 2 weeks of the first dose of XmAb13676


  • Moores UC San Diego Cancer Center in progress, not accepting new patients
    La Jolla California 92093 United States
  • Swedish Cancer Institute accepting new patients
    Seattle Washington 98104 United States


accepting new patients
Start Date
Completion Date
Xencor, Inc.
Phase 1
Study Type
Last Updated