Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies
Trial Status: Active
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).
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 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)
- Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
- 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.
- Not a candidate for or refusing treatment with hematopoietic stem cell transplantation Additional Patient Inclusion Criteria for the Follicular Lymphoma Cohort (Expansion Phase)
- Diagnosis of follicular lymphoma Grades 1-3a
- Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.
Exclusion Criteria
- 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 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 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
California
San Diego
UC San Diego Medical Center - Hillcrest
Status: CLOSED_TO_ACCRUAL
Contact: Erin Gourley Reid
Phone: 858-822-5354
Email:
cancercto@ucsd.edu
Florida
Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Illinois
Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Texas
Houston
M D Anderson Cancer Center
Status: ACTIVE
Virginia
Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Trial Phase Phase I
Trial Type Treatment
Lead Organization
Xencor, Inc.
- Primary ID XmAb13676-01
- Secondary IDs NCI-2016-01843
- Clinicaltrials.gov ID NCT02924402