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Trial of Hu5F9-G4 in Combination With Rituximab in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT02953509
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Forty Seven, Inc.

Brief Summary:

This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is used for treatment of non-Hodgkin's lymphoma and other types of cancer.

The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in combination with rituximab in patients with indolent lymphoma or diffuse large B-cell lymphoma as measured by the overall response rate.


Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Indolent Lymphoma Drug: Hu5F9-G4 Drug: Rituximab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Study Start Date : November 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Phase 1b dose escalation
In Phase 1b, patients with non-Hodgkin's lymphoma will receive escalating doses of Hu5F9-G4 in combination with ritixumab.
Drug: Hu5F9-G4
Hu5F9-G4 infusions will be administered weekly.
Drug: Rituximab
Rituximab infusions will be administered weekly for one cycle (28 days) and then every 4 weeks up to 6 cycles.
Other Name: RITUXAN®
Experimental: Phase 2 indolent lymphoma
In Phase 2, patients with indolent lymphoma will receive Hu5F9-G4 in combination with ritixumab.
Drug: Hu5F9-G4
Hu5F9-G4 infusions will be administered weekly.
Drug: Rituximab
Rituximab infusions will be administered weekly for one cycle (28 days) and then every 4 weeks up to 6 cycles.
Other Name: RITUXAN®
Experimental: Phase 2 diffuse large B-cell lymphoma
In Phase 2, patients with diffuse large B-cell lymphoma will receive Hu5F9-G4 in combination with ritixumab.
Drug: Hu5F9-G4
Hu5F9-G4 infusions will be administered weekly.
Drug: Rituximab
Rituximab infusions will be administered weekly for one cycle (28 days) and then every 4 weeks up to 6 cycles.
Other Name: RITUXAN®



Primary Outcome Measures :
  1. Dose-limiting toxicities (Number of participants with a DLT) [ Time Frame: 28 days ]
    Dose-limiting toxicities (DLTs) (Phase 1b only) Number of participants with a DLT

  2. Objective response (defined by the Investigator according to the Lugano classification for lymphomas) [ Time Frame: 8 weeks ]
    Phase 2: Objective response as defined by the Investigator according to the Lugano classification for lymphomas



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

Inclusion Criteria:

  • Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies
  • DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to frontline or second line treatment or autologous hematopoietic cell transplantation
  • Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies
  • Adequate performance status and hematological, liver and kidney functions
  • Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Exclusion Criteria:

  • Active brain metastases
  • Prior allogeneic hematopoietic cell transplantation
  • Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents
  • Second malignancy within the last 3 years
  • Known active or chronic hepatitis B or C infection or HIV
  • Pregnancy or active breastfeeding

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): NCT02953509


Contacts
Contact: Mark Chao, MD PhD 650-352-4150 medical@fortyseveninc.com
Contact: David Rhodes medical@fortyseveninc.com

Locations
United States, Alabama
University of Alabama At Birmingham (Uab) Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Hope Line Patient Referral    205-996-4673    phase1referral@uab.edu   
Principal Investigator: Andres Forero, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Imran Qasim    626-218-9108    iqasim@coh.org   
Principal Investigator: Leslie Popplewell         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Sipra Choudhury, M.Sc,CCRP    650-736-2563    schoudhury@stanford.edu   
Contact: Thu Tran    650-723-0530    Ttran49@stanford.edu   
Principal Investigator: Ranjana Advani, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jennifer Madden    773-834-4574    jmadden@medicine.bsd.uchicago.edu   
Principal Investigator: Sonali Smith, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Arrika Rayburn    314-747-7399    arayburn@wustl.edu   
Principal Investigator: Nancy Bartlett, MD         
United States, North Carolina
Carolinas Healthcare Systems- Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28024
Contact: Angela Anderson    980-442-2365    angela.p.anderson@carolinashealthcare.org   
Principal Investigator: Nilanjan Ghosh, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ian Flinn, MD         
Contact    615-339-4214    asksarah@sarahcannon.com   
Principal Investigator: Ian Flinn, MD         
Sponsors and Collaborators
Forty Seven, Inc.
The Leukemia and Lymphoma Society
Investigators
Study Chair: Mark Chao, MD PhD Forty Seven, Inc.

Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT02953509     History of Changes
Other Study ID Numbers: 5F9003
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Forty Seven, Inc.:
non-Hodgkin's lymphoma
diffuse large B-cell lymphoma
indolent lymphoma
Hu5F9-G4
CD47

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents