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

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: NCT02953509
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : February 25, 2020
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 (magrolimab) in combination with rituximab and magrolimab or in combination with R-GemOx. Magrolimab is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with magrolimab 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. Gemcitabine and Oxaliplatin are chemotherapy commonly used with rituximab in treating NHL.

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 Drug: Gemcitabine Hydrochloride Drug: Oxaliplatin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 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 or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Study Start Date : November 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Phase 1b dose escalation
In Phase 1b, patients with B-cell non-Hodgkin's lymphoma will receive escalating doses of Hu5F9-G4 in combination with ritixumab.
Drug: Hu5F9-G4
Other Name: magrolimab

Drug: Rituximab
Other Names:
  • RITUXAN®
  • MabThera

Experimental: Phase 2 indolent lymphoma
In Phase 2, patients with indolent lymphoma will receive Hu5F9-G4 in combination with ritixumab.
Drug: Hu5F9-G4
Other Name: magrolimab

Drug: Rituximab
Other Names:
  • RITUXAN®
  • MabThera

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
Other Name: magrolimab

Drug: Rituximab
Other Names:
  • RITUXAN®
  • MabThera

Experimental: Phase 1b diffuse large B-cell lymphoma
In Phase 1b, patients with diffuse large B-cell lymphoma will receive escalating doses of magrolimab in combination with ritixumab + gemcitabine and oxaliplatin.
Drug: Hu5F9-G4
Other Name: magrolimab

Drug: Rituximab
Other Names:
  • RITUXAN®
  • MabThera

Drug: Gemcitabine Hydrochloride
Other Name: Gemzar

Drug: Oxaliplatin
Other Name: Eloxatin




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


Secondary Outcome Measures :
  1. PK profile [ Time Frame: up to 52 weeks ]
    Concentration vs time of magrolimab in combination with rituximab or rituximab +GemOx

  2. ADA to magrolimab [ Time Frame: up to 52 weeks ]
    Presence or absence of antibodies

  3. Duration of response; Progression Free Survival, Overall Survival, Time to Progression [ Time Frame: up to 40 months ]
    Response data over time as defined by the investigator according to Lugano and LYRIC criteria

  4. Objective Rate of Response [ Time Frame: 8 weeks ]
    Assessed Investigator according to LYRIC criteria for lymphomas



Information from the National Library of Medicine

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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:

  • 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) expressing CD 20, relapsed or refractory to at least 2 prior lines treatment containing anti-CD20 therapy
  • Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies
  • DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment
  • Adequate performance status and hematological, liver and kidney functions
  • 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
  • Prior CAR-T therapy

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
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Contact: Mwe Mwe Chao, MD 650-352-4133 medical@fortyseveninc.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Forty Seven, Inc.
The Leukemia and Lymphoma Society
Investigators
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Study Chair: Mwe Mwe Chao, MD Forty Seven, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT02953509    
Other Study ID Numbers: 5F9003
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Forty Seven, Inc.:
non-Hodgkin's lymphoma
diffuse large B-cell lymphoma
indolent lymphoma
Hu5F9-G4
CD47
magrolimab
Additional relevant MeSH terms:
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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
Gemcitabine
Rituximab
Hu5F9-G4
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents