Hu5F9-G4: a phase 1/2 trial testing a new drug, Hu5F9-G4, with rituximab for people with relapsed or refractory non-Hodgkin lymphoma

The aim of this trial is testing the combination of Hu5F9-G4 and rituximab to treat people with B-cell non-Hodgkin lymphoma that has come back (relapsed) or didn’t respond (was refractory) to previous treatment.

Purpose of trial

The trial is in 2 parts.

The first part of the trial aims to find the best dose of Hu5F9-G4 to use in combination with rituximab for people with B-cell non-Hodgkin lymphoma.

The second part tests the safety and effectiveness of the dose selected in the first part in people with certain types of non-Hodgkin lymphoma:


Treatments

Hu5F9-G4 is a new antibody treatment that targets a protein called ‘CD47’, which is found on cancer cells.

Rituximab is an antibody treatment already widely used to treat people with non-Hodgkin lymphoma.

Everyone in this trial has Hu5F9-G4 and rituximab. Both drugs are given intravenously (into a vein). You have Hu5F9-G4 once a week for the first month then every two weeks thereafter. You have rituximab once a week for 4 weeks then once every 4 weeks. You can have up to six cycles of treatment (a cycle is 4 weeks).

  • In part 1, different doses of Hu5F9-G4 are being tested. Everyone has the same dose of rituximab. A few people are treated with a low dose of Hu5F9-G4 with rituximab. If this doesn’t cause troublesome problems, the next few people have a higher dose of Hu5F9-G4 with rituximab. This continues until the highest safe dose is found. The most effective safe dose is used in the second part of the trial.
  • In part 2, everyone has the dose of Hu5F9-G4 selected in part 1 together with rituximab.

Who can enter

Your consultant can give you advice on whether this trial might be suitable for you.

Up to 72 people are needed for this trial.

You may be able to enter if:

  • You have B-cell non-Hodgkin lymphoma (DLBCL, follicular lymphoma or marginal zone lymphoma).
  • You have had previous treatment for your lymphoma.
  • Your blood and other health test results are satisfactory and you are well enough to take part in this trial.
  • You are willing to have a biopsy before treatment and during treatment (part 2 only).
  • You are 18 or over.

You will not be able to enter if:

  • Your lymphoma is affecting your central nervous system (brain and spinal cord).
  • You have had a donor stem cell transplant (allogeneic stem cell transplant).
  • You have been treated with a similar drug before.
  • You have had another cancer in the last 3 years.
  • You have HIV, hepatitis B or hepatitis C.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov