Summary
This is a clinical trial for adults with large B-cell lymphoma (LBCL) who have finished their standard treatment. People can take part if their lymphoma has responded well to treatment (either a complete response or a partial response that does not need further treatment right now), but there is still a very small amount of disease left that can only be picked up by a sensitive blod test. This is called minimal residual disease (MRD).
The aim of the study is to find out whether giving an extra treatment called cemacabtagene ansegedleucel (cema-cel) is safe and works better than the usual approach, which is careful monitoring without treatment (also known as observation).
Cema-cel is a type of CAR T-cell therapy made from donor immune cells that are designed to recognise and attack lymphoma cells.
If you take part and are found to have MRD, you will be randomly assigned (by chance) to one of two groups:
- one group receives cema-cel treatment
- the other group is placed on observation only, which is the current standard approach.
Before receiving cema-cel, participants have a short course of chemotherapy medicines (fludarabine and cyclophosphamide). This is done to prepare the body so the CAR T-cells can work effectively.
The study will compare how well these two approaches work and monitor any side effects, to help guide future treatment for people with LBCL.
Conditions
This trial is treating people with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or primary mediastinal B-cell lymphoma