Clinical Trials /

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

NCT02924402

Description:

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.

Related Conditions:
  • B-Cell Neoplasm
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies
  • Official Title: A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 in Patients With CD20-Expressing Hematologic Malignancies

Clinical Trial IDs

  • ORG STUDY ID: XmAb13676-01
  • NCT ID: NCT02924402

Conditions

  • B-cell Non-Hodgkins Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
XmAb13676Non-CLL B Cell Malignancies (Group NHL)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Non-CLL B Cell Malignancies (Group NHL)ExperimentalXmAb13676 administered IV weekly up to 8 weeks
  • XmAb13676
CLL/SLL (Group CLL)ExperimentalXmAb13676 administered IV weekly up to 8 weeks
  • XmAb13676

Eligibility 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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety as determined by the number of participants with treatment-related adverse events
Time Frame:Baseline Day 1 through Day 56
Safety Issue:
Description:treatment-related adverse events as assessed by CTCAE v4.03

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Xencor, Inc.

Trial Keywords

  • 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

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