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

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ClinicalTrials.gov Identifier: NCT02924402
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Xencor, Inc.

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date March 25, 2021
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2020)
  • Safety as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Baseline Day 1 through Day 56 ]
  • Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing [ Time Frame: Baseline Day 1 through Day 56 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Baseline Day 1 through Day 56 ]
  • Maximum tolerated (MTD) and/or recommended dose (RD) [ Time Frame: Baseline Day 1 through Day 56 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies
Official Title  ICMJE A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 in Patients With CD20-Expressing Hematologic Malignancies
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will enroll two parallel disease groups in escalation: patients with non-CLL B cell malignancies and patients with CLL/SLL/Richter's Transformation.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B-cell Non-Hodgkins Lymphoma
  • Chronic Lymphocytic Leukemia
Intervention  ICMJE Biological: XmAb13676
Biological
Study Arms  ICMJE
  • Experimental: Non-CLL B Cell Malignancies (Group NHL)
    XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
    Intervention: Biological: XmAb13676
  • Experimental: CLL/SLL (Group CLL)
    XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
    Intervention: Biological: XmAb13676
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2020)
216
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
65
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 4 weeks 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.

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

  1. Diagnosis of mantle cell lymphoma
  2. Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.

Additional Patient Inclusion Criteria for the Waldenström Macroglobulinemia Cohort (Expansion Phase)

  1. Diagnosis of Waldenström macroglobulinemia
  2. Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.

Additional Patient Inclusion Criteria for Richter Transformation Cohort (Expansion Phase)

1. Diagnosis of Richter transformation Additional Patient Inclusion Criteria for Other Indolent Lymphomas Cohort (Expansion Phase)

  1. Diagnosis of other indolent B-cell, non-Hodgkin's lymphomas, specifically the following: MALT lymphoma, nodal marginal zone lymphoma, and splenic marginal zone lymphoma (NOTE: SLL is not eligible)
  2. 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, up to the End of Study visit
  • Positive urine pregnancy test (ie, urine human chorionic gonadotropin) at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Liebowitz, MD 858-617-6160 ext 260 dliebowitz@xencor.com
Contact: Chelsea Johnson 858-480-3891 ext 159 cjohnson@xencor.com
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02924402
Other Study ID Numbers  ICMJE XmAb13676-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xencor, Inc.
Study Sponsor  ICMJE Xencor, Inc.
Collaborators  ICMJE ICON Clinical Research
Investigators  ICMJE
Study Director: David Liebowitz, MD VP, Clinical Oncology, Clinical Development, Xencor, Inc.
PRS Account Xencor, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP