Betalutin: a phase 1 study to find the best dose of a new treatment called betalutin for people with diffuse large B-cell lymphoma that has come back or not responded to treatment

This is a small 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 the best dose of a new treatment called betalutin. This trial is for people who have diffuse large B-cell lymphoma (DLBCL) that is refractory (has not responded to treatment) or has relapsed (come back) and who are not able to have a stem cell transplant. The trial also looks at:

  • any side effects
  • how well the treatment works
  • how the treatment behaves in the body.

Treatments

Betalutin is also called Lutetium (177Lu)-Lilotomab Satetraxetan. This is an antibody joined to a radioactive molecule called lutetium 177. The antibody targets a protein found on the surface of some lymphoma cells, called CD37. The antibody carries the radioactive molecule to the lymphoma cells and the radiation then kills them.

This trial aims to find out the highest safe dose of the treatment. This is done by ‘dose escalation’. Participants are treated in groups. The first participants have the lowest dose. The next group 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 then used to further test the treatment.

Each participant has a single injection of the trial treatment.

The researchers also collect information about side effects, how well the treatment appears to work and how the body processes the treatment.


Who can enter

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

A total of 18 people are needed for this trial.

You may be able to enter if

  • You have diffuse large B cell lymphoma (DLBCL) that has come back or has not responded to treatment.
  • You are not able to have a stem cell transplant to treat your DLBCL.
  • You have previously had at least 1 course of treatment for your lymphoma.
  • Your lymphoma is measurable by the tests used in the trial.
  • Your blood and other health test results are satisfactory.
  • You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
  • You and your partner are willing to use reliable contraception, from a month before treatment until a year after, if there is any chance of pregnancy. Women must use two methods of contraception and men must use condoms during this time. You agree to have a pregnancy test before having the trial treatment if there is any chance that you could be pregnant.
  • You are 18 or over.

You will not be able to enter if

  • You have previously had a stem cell transplant.
  • You have previously had radiotherapy to more than a quarter (25%) of your bone marrow.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have had conditions called Steven’s Johnson’s syndrome, toxic epidermal necrolysis syndrome or erythema multiforme in the past.
  • You have been treated with a similar drug before.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You’ve had lymphoma treatment in the last 4 weeks.
  • You have had another cancer in the last 5 years, except certain localised cancers.
  • You are having treatment with any other trial drugs.
  • You’ve been vaccinated with a live vaccine in 30 days before joining the trial.
  • You have HIV, hepatitis C or hepatitis B.
  • You are pregnant or breastfeeding.
  • Any of the study drugs are not suitable for you.
  • You are known to be allergic to dyes used in X-rays or any of the antibodies or proteins in the trial treatment.

Further information

More information about this trial is available at clinicaltrials.gov.