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Trial record 1 of 1 for:    NCT02924402
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Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924402
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : March 1, 2023
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Xencor, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).

Condition or disease Intervention/treatment Phase
B-cell Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia Biological: XmAb13676 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
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. In expansion it will enroll DLBCL and FL
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-Expressing Hematologic Malignancies
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part A
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
 Biological: XmAb13676
Biological
Experimental: CLL/SLL (Group CLL) Part A
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
 Biological: XmAb13676
Biological
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part B
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
 Biological: XmAb13676
Biological
Experimental: CLL/SLL (Group CLL) Part B
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
 Biological: XmAb13676
Biological
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
 Biological: XmAb13676
Biological
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion
XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
 Biological: XmAb13676
Biological


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability 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 ]
  2. Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing [ Time Frame: Baseline Day 1 through Day 56 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide written informed consent
  • Diagnosis of either Non-CLL B cell malignancy
  • 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.

Exclusion Criteria:

  • Cytotoxic chemotherapy, radiotherapy, or immunotherapy including other anti-CD20 antibodies within 4 weeks, or small molecule or investigational agents within 5 elimination half-lives of the first dose of XmAb13676
  • Prior 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 < 40 mL/min
  • Active/uncontrolled autoimmune disease
  • Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
  • Seizure disorder
  • History of stroke with the past 6 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 or HBV-DNA is negative and patient is receiving Hep B reactivation prophylaxis.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924402


Contacts
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Contact: Steve Kye, MD, MPH 858-243-9970 skye@xencor.com
Contact: Phuong Lee 858-480-3115 ext 215 plee@xencor.com

Locations
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Sponsors and Collaborators
Xencor, Inc.
ICON Clinical Research
Investigators
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Study Director: Steve Kye, MD, MPH Executive Medical Director, Clinical Development, Xencor, Inc.
More Information
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02924402    
Other Study ID Numbers: XmAb13676-01
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xencor, Inc.:
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
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Neoplasms
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, B-Cell
Neoplasms by Site
Hematologic Diseases