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



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:October 2016
End Date:September 2020
Contact:David Liebowitz, MD
Email:dliebowitz@xencor.com
Phone:858-617-6160

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

The purpose of this study is to determine the safety and tolerability of weekly intravenous
(IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after
the first dose, and then to determine the MTD after second and subsequent infusions.


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
We found this trial at
9
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-647-8901
University of Michigan The University of Michigan was founded in 1817 as one of the...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Phone: 904-953-3238
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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1215 Lee Street
Charlottesville, Virginia 22908
Phone: 434-982-4982
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Charlottesville, VA
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303 East Superior Street
Chicago, Illinois 60611
Phone: 312-695-0990
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Columbus, OH
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Creteil, 94000
Phone: 33 1 49 81 20 51
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Creteil,
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Houston, Texas 77030
Phone: 713-792-2860
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Houston, TX
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La Jolla, California 92093
Phone: 858-822-7916
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La Jolla, CA
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Seattle, Washington 98104
Phone: 206-215-2338
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Seattle, WA
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