Purpose of trial
The aim of this trial is to find the best dose of a new treatment called ‘BAY 1862864 Injection’ for non-Hodgkin lymphoma that has relapsed (come back) or is refractory (has not responded to treatment. This trial also looks at:
- how the treatment behaves in the body
- what side effects it may cause
- how well the treatment works.
BAY 1862864 injection is a thorium-227 radiolabelled antibody-chelator conjugate. This means it includes both an antibody and radioactivity (thorium-227). The antibody targets a protein found on the surface of some lymphoma cells, called CD22. The antibody carries the radioactivity directly to the lymphoma cells, reducing its effects on healthy cells.
This trial is in two parts:
- Part 1 is to find out the highest safe dose of BAY 1862864 Injection. This is done by ‘dose escalation’. Participants are treated in small groups. The first group have the lowest dose of BAY 1862864 Injection. The next group have a higher dose. This continues and the participants are monitored closely for side effects until the highest safe dose is reached. One of the doses is selected to be tested in more participants in part two of the trial.
- Part 2 is to test how well the selected dose of BAY 1862864 Injection works. People entering this part of the trial all have the same dose of BAY 1862864 Injection.
All participants can have up to four cycles of treatment. Each cycle of treatment lasts 6 weeks and BAY 1862864 Injection is given on the first day of each cycle. The trial treatment is given as an injection.
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
The trial team can advise you whether you are suitable for this trial and whether any other conditions or treatments you have or have had prevent you from entering the trial.
Around 60 people are needed for this trial.
You may be able to enter if:
- You have non-Hodgkin lymphoma that has come back or has not responded to treatment.
- Your lymphoma cells have CD22 (the target for the trial treatment).
- Your lymphoma is in less than a quarter of your bone marrow.
- You have already had or are not able to have a stem cell transplant to treat your lymphoma.
- 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 take part in the trial.
- You and your partner are willing to use reliable contraception, from before treatment until a year after, if there is any chance of pregnancy.
- 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 won't be able to enter if:
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment. This includes heart problems, high blood pressure, a history of blood clots, liver problems or an active infection.
- You still have significant side effects from previous anti-cancer treatment.
- You have been treated with the trial treatment before or have had a similar drug in the last 6 months
- You’ve had lymphoma treatment, including chemotherapy, antibody therapy, radiotherapy and other experimental treatments, in the last 4 weeks.
- You’ve had a treatment including fludarabine in the last 3 months.
- You’ve had an autologous stem cell transplant in the last 3 months.
- You’ve had major surgery or a major accident in the last 4 weeks.
- You’ve ever had an allogeneic stem cell transplant or an organ transplant (except a cornea transplant).
- You’ve had supportive care such as growth factors, blood transfusions or similar treatments in the last 3 weeks.
- You have ever had tumours in your brain that caused symptoms.
- You’ve had another cancer.
- You’ve been vaccinated with a live vaccine in 30 days before joining the trial.
- You have HIV, hepatitis C virus or hepatitis B virus.
- You are pregnant or breastfeeding.
- Any of the study drugs are not suitable for you.
More information about this trial is available at clinicaltrials.gov.