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



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:November 2016
End Date:January 2023
Contact:Mark Chao, MD PhD
Email:medical@fortyseveninc.com
Phone:650-352-4150

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A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

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.


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
We found this trial at
12
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Ian Flinn, MD
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-9920
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Sonali Smith, MD
Phone: 773-702-9791
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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NIH
Bethesda, Maryland 20892
Principal Investigator: Mark Roschewski, MD
Phone: 240-760-6013
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Bethesda, MD
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Birmingham, Alabama 35294
Principal Investigator: Amitkkumar Mehta, MD
Phone: 205-934-5367
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Birmingham, AL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Ann LaCasce, MD
Phone: 617-632-6840
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Charlotte, North Carolina 28277
Principal Investigator: Nilanjan Ghosh, MD
Phone: 980-442-2365
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Charlotte, NC
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Duarte, California 91010
Principal Investigator: Leslie Popplewell
Phone: 626-218-9108
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Duarte, CA
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Oklahoma City, Oklahoma 73104
Principal Investigator: Adam Asch, MD
Phone: 405-271-8778
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Oklahoma City, OK
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Oxford, Oxforshire
Principal Investigator: Graham Collins, MB
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Palo Alto, California 94304
Principal Investigator: Ranjana Advani, MD
Phone: 650-721-4096
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Nancy Bartlett, MD
Phone: 314-747-7399
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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