AUTO4 in T-cell lymphoma: a phase 1/2 trial testing AUTO4 CAR-T cells as treatment for people with T-cell lymphoma that has relapsed (come back) or was refractory (didn’t respond) to previous treatment
A phase 1/2 trial testing a new type of CAR-T therapy called AUTO4 in people with certain types of T-cell non-Hodgkin lymphoma: peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and anaplastic large cell lymphoma (ALCL).
You can share the following ClinicalTrials.gov Identifier with your medical team so they can find out more about the trial: NCT03590574
Trial aim and background
The aim of this trial is to find out more about a new type of CAR-T therapy, AUTO4, in people with T-cell lymphomas.
T-cell lymphoma commonly relapses, and relapsed or refractory T-cell lymphoma is often difficult to treat. This trial is testing whether AUTO4 CAR-T cells are safe and effective for people who have had previous treatment for T-cell lymphoma but need more treatment.
The trial aims to find out:
- if AUTO4 CAR-T cells are safe for people with T-cell lymphoma
- what the most effective, safe dose of AUTO4 CAR-T cells is
- how effective AUTO4 CAR-T cells are in treating T-cell lymphoma
Everyone in this trial receives AUTO4 CAR-T cells if they can be successfully manufactured. It is not always possible to modify the T cells or produce enough AUTO4 CAR-T cells. If this happens, alternative treatment options will be discussed.
Patients are monitored carefully in hospital during and after the treatment. They must still be well enough to have the AUTO4 CAR-T cell treatment when it is ready. If they are not well enough to continue in the trial, treatment may be delayed other treatment options will be discussed.
There are two phases in this study. People enter either phase 1 or phase 2.
- In phase 1, several different doses of AUTO4 CAR-T cells are being tested. The first few participants have the lowest dose being tested. If this doesn’t cause troublesome problems, the next few people have a higher dose. If the higher dose doesn’t cause troublesome problems, the last few people have the highest dose.
- In phase 2, the safest and most effective dose from phase 1 of the trial is tested in more people.
Regular blood tests happen after treatment to see how it is affecting the body and the lymphoma.
Who can enter
Adults over 18 with peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma or anaplastic large cell lymphoma that has relapsed or become refractory to treatment may be eligible for this trial.
Locations
Recruitment is taking place in the following UK locations:
- Queen Elizabeth University Hospital, Glasgow
- University College London Hospitals NHS Trust, London
- Manchester Royal Infirmary Hospital, Manchester
- Freeman Hospital, Newcastle
Further information
More information about what treatments are involved, the criteria you must meet in order to take part in the trial and where this trial is taking place are available at: https://beta.clinicaltrials.gov/study/NCT03590574
Lymphoma Action are not able to refer people to specific trials. If you are interested in taking part in this trial we recommend that you print the trial summary and discuss it with your medical team. They can advise you on whether you might be eligible for the trial and how you can take part based on your individual circumstances.