CCS1477-02: a phase 1/2a study of CCS1477 in blood cancers, including relapsed or refractory non-Hodgkin lymphoma

This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment, but the trial will give important information about this new treatment, which could help other people in the future.


Purpose of trial

The aim of this trial is to find out more about a new treatment called CCS1477 for people with non-Hodgkin lymphoma and other types of blood cancer that have come back (relapsed) or has not responded (refractory) after previous treatment.

The trial aims to find out:

  • the best dose of CCS1477 to use
  • what side effects CCS1477 might have
  • how well CCS1477 works
  • how CCS1477 behaves in the body.

Treatments

CCS1477 is a new targeted drug. It works by blocking particular types of proteins called histone acetyltransferases (HATs). HATs help control the way blood cells develop by altering the activity of genes and affecting what proteins a cell makes. Blocking the action of HATs can interfere with the development of cancerous blood cells.

Everyone in this trial has treatment with CCS1477. You have it as a capsule that you take by mouth (orally). You keep taking it until the trial finishes unless your lymphoma gets worse or you have troublesome side effects.

The trial is in two parts: 

  • Part 1 is to find out the highest safe dose of CCS1477. This is done by ‘dose escalation’. Participants are treated in groups of three. The first three participants have the lowest dose. The next three have a higher dose. This continues and the participants are monitored closely for side effects. The highest dose that doesn’t cause serious side effects is used in part 2 of the trial.
  • Part 2 is to test how well the highest safe dose of CCS1477 works. People entering this part of the trial all have the same dose of CCS1477.

Who can enter

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

Around 90 people are needed for this trial.

You may be able to enter if:

You have relapsed or refractory non-Hodgkin lymphoma.
Your lymphoma is measurable by the tests used in the trial.
You have previously had at least one course of treatment for your lymphoma.
You are well enough to take part in the trial.
Your blood and other health test results are satisfactory.
You are able to stop taking statin treatment (cholesterol-lowering medicines) if you are on any.
You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
You are 18 or over.

You won’t be able to enter if:

You have any serious or uncontrolled health problems.
You have any other health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
You still have significant side effects from your previous treatment. 
You’ve had major surgery in the last 4 weeks.
You have a particular ECG (heart tracing) abnormality.
You have taken certain other drugs with in the last 2 to 4 weeks. 
You are pregnant or breastfeeding.


Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT04068597.