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

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

sites

NIH

Bethesda, Maryland 20892

Principal Investigator: Mark Roschewski, MD

Phone: 240-760-6013

from

Bethesda, MD