NCT02924402

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_1

Geographic Reach
4 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

7.5 years

First QC Date

September 14, 2016

Last Update Submit

November 12, 2024

Conditions

B-cell Non-Hodgkins LymphomaChronic Lymphocytic Leukemia

Keywords

NHLB-cell Prolymphocytic LeukemiaTransformed LymphomaBurkitt's LymphomaMantle Cell LymphomaHairy Cell LeukemiaSplenic Marginal Zone LymphomaWaldenstrom's MacroglobulinemiaVariant Hairy Cell LeukemiaSplenic B-cell Lymphoma/LeukemiaLymphoplasmacytic LymphomaExtranodal Marginal Zone Lymphoma (MALT)MALT LymphomaNodal Marginal Zone LymphomaFollicular LymphomaIn Situ Follicular NeoplasiaDuodenal-type Follicular LymphomaLarge B-cell Lymphoma with IRF4 rearrangementPrimary Cutaneous Follicle Center LymphomaDiffuse Large B-cell LymphomaDLBCLT-cell/Histiocyte-Rich Large B-cell LymphomaPrimary Cutaneous DLBCL, leg typeEBV-positive DLBCL, NOSEBV-positive Mucocutaneous UlcerDLBCL Associated with Chronic InflammationLymphomatoid GranulomatosisPrimary Mediastinal (Thymic) Large B-cell LymphomaIntravascular Large B-cell LymphomaALK+ Large B-cell LymphomaPlasmablastic LymphomaPrimary Effusion LymphomaHHV8+ DLBCLBurkitt-like Lymphoma with 11q AberrationHigh-grade B-cell LymphomaB-cell Lymphoma, unclassifiablePost-transplant Lymphoproliferative DisorderPTLDSLLHigh-grade LymphomaRichter's Transformation

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03

    Baseline Day 1 through Day 56

  • Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing

    Baseline Day 1 through Day 56

Study Arms (6)

Non-CLL B Cell Malignancies (Group NHL) Part A

EXPERIMENTAL

XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion

Biological: XmAb13676

CLL/SLL (Group CLL) Part A

EXPERIMENTAL

XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion

Biological: XmAb13676

Non-CLL B Cell Malignancies (Group NHL) Part B

EXPERIMENTAL

XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion

Biological: XmAb13676

CLL/SLL (Group CLL) Part B

EXPERIMENTAL

XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion

Biological: XmAb13676

Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion

EXPERIMENTAL

XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion

Biological: XmAb13676

Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion

EXPERIMENTAL

XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion

Biological: XmAb13676

Interventions

XmAb13676BIOLOGICAL

Biological

CLL/SLL (Group CLL) Part ACLL/SLL (Group CLL) Part BNon-CLL B Cell Malignancies (Group NHL) Part ANon-CLL B Cell Malignancies (Group NHL) Part BNon-CLL B Cell Malignancies (Group NHL) Part C / ExpansionNon-CLL B Cell Malignancies (Group NHL) Part D / Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Moores UC San Diego Cancer Center

La Jolla, California, 92093, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

The Ohio State University Wexner Medical Center and James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UVA Health System, Division of Hematology & Oncology

Charlottesville, Virginia, 22908, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, 33076, France

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Institut Paoli Calmette Dpt of Oncology/Hematology

Marseille, 13273, France

Location

Chu Montpellier, Hematologie Clinique St. Eloi

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Haut-Leveque, Service d'Hematologie Clinique et Therapie Cellulaire

Pessac, 33604, France

Location

Centre Hospitalier Lyon-Sud, Service d'Hematologie

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31100, France

Location

CLCC Institut Gustave Roussy

Villejuif, 94805, France

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Prolymphocytic, B-CellBurkitt LymphomaLymphoma, Mantle-CellLeukemia, Hairy CellWaldenstrom MacroglobulinemiaLeukemiaLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularLymphoma, Large B-Cell, DiffusePyloric Stenosis, HypertrophicLymphomatoid GranulomatosisPlasmablastic LymphomaLymphoma, Primary EffusionLymphoma, B-CellLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, ProlymphocyticEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersPyloric StenosisGastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesPrecancerous Conditions

Study Officials

  • Chet Bohac, PharmD, MD, MSc

    Executive Medical Director, Clinical Development, Xencor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

October 5, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)US(10)GB(1)KR(1)