Hu5F9-G4 + Rituximab + Chemotheraphy in Relapsed/Refractory B Cell NHL
Research type
Research Study
Full 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
IRAS ID
252988
Contact name
Graham Collins
Contact email
Sponsor organisation
Forty Seven Inc.
Eudract number
2016-003408-29
Clinicaltrials.gov Identifier
118300, US IND Number
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
In this research study an investigational drug Hu5F9-G4 is being tested. Hu5F9-G4 is an immunotherapy, consisting of an antibody that targets and blocks a protein called CD47, allowing immune cells to destroy cancer cells. CD47 is an anti-phagocytic “don’t eat me signal”, whereby blockade by Hu5F9-G4 leads to phagocytosis and elimination of tumor cells.
Hu5F9-G4 will be administered with the clinically approved anti-CD20 antibody rituximab for non- Hodgkin’s lymphoma. In pre-clinical models, Hu5F9-G4 combination with rituximab led to synergistic anti-tumor activity. Hu5F9-G4 is currently being investigated in patients with solid tumors, lymphomas, and acute myeloid leukemia.
Preliminary experience has shown that Hu5F9-G4 has been well-tolerated with the exception of red blood cell elimination, leading to a predictable and transient anemia that is a known consequence of blocking CD47 on red cells.
This study will look at the safety and tolerability of Hu5F9-G4 and rituximab (antibody combination) and Hu5F9-G4 + R-GemOx (Chemotherapy combination) with Gemcitabine and Oxaliplatin administration, the optimal dose of the combination, and anti-tumor efficacy.
Approximately 322 patients will be enrolled in this research study. Patients may continue on the study drug as long as they are tolerating the treatment and the cancer has not progressed or the study is not stopped.
Otherwise it is anticipated that this study will take approximately 22 months to complete.
Approximately 16 sites located in the US and United Kingdom will be included in this trial.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0298
Date of REC Opinion
4 Nov 2019
REC opinion
Further Information Favourable Opinion