In short
Clinical trials are studying Lisocabtagene Maraleucel in people with several blood cancers, especially different types of lymphoma. These studies look at how well the treatment works and how safe it is, in both newly diagnosed and relapsed or hard-to-treat patients.
Key points
- Clinical trials of Lisocabtagene Maraleucel are studying several blood cancer settings, especially different types of lymphoma. Most of the trials are Phase 2 studies, with one Phase 3 study and one long-term Phase 4 follow-up study. The target groups include adults with relapsed or refractory disease, adults with newly diagnosed primary central nervous system lymphoma, and some patients who previously received gene-modified T-cell therapy. The main goals are to measure how well the treatment works, such as response rates and complete responses, and to track safety over time. One study also looks at long-term outcomes like survival, cancer progression, and delayed side effects. Some trials include Lisocabtagene Maraleucel alone, while others study it as part of broader CAR-T treatment plans.
Trial overview
The trial data show several studies that investigate Lisocabtagene Maraleucel in blood cancers, with a strong focus on lymphoma. These studies are designed to learn how well the treatment works and how safe it is in different patient groups.
Most of the listed studies are interventional trials, which means researchers give a treatment and then measure the results. The trials include both standalone studies and studies where Lisocabtagene Maraleucel is part of a larger treatment plan or long-term follow-up program.
Conditions and patient groups
One study looks at adults with relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma, which means a slow-growing lymphoma that either came back after treatment or did not respond well to treatment. This study includes follicular lymphoma and marginal zone lymphoma, and it aims to test treatment effect in these specific subtypes.
Another study focuses on adults with Primary Central Nervous System Lymphoma, and it is designed for people who are unable to undergo autologous stem cell transplant. The trial asks whether Lisocabtagene Maraleucel can help stop the cancer from getting worse within one year after treatment.
Other studies include people with relapsed or refractory aggressive large B-cell lymphoma or relapsed/refractory Large B-Cell Lymphoma, including patients at high risk of relapse. These trials are aimed at harder-to-treat disease, where researchers want to improve response after CAR-T therapy or use it in a broader treatment strategy.
One long-term follow-up study includes adult and pediatric participants who previously received at least one genetically modified T-cell infusion in an earlier Celgene-sponsored study, including Lisocabtagene Maraleucel. This study is not limited to one cancer type and instead follows people over time for safety and long-term outcomes.
Trial phases and study designs
The listed studies include Phase 2, Phase 3, and Phase 4 trials. Phase 2 studies usually look closely at whether a treatment works in a specific disease group and continue to monitor safety.
The Phase 3 study in the data is the VESICANS study, which examines changes in extracellular vesicles during CAR-T therapy and during immune effector cell-associated neurotoxicity syndrome, also called ICANS. This study uses several CAR-T products and is focused on hematology, or blood-related diseases.
The Phase 4 study is a long-term follow-up protocol for people treated with gene-modified T cells. It tracks participants for up to 15 years after the last infusion, showing that some research is meant to understand delayed effects and long-term recovery rather than short-term response only.
What the trials measure
Several trials measure overall response rate, which means the percentage of patients whose cancer shrinks or disappears after treatment. In the indolent lymphoma study, this is assessed by PET-CT for follicular lymphoma or by CT for marginal zone lymphoma using the Lugano Classification.
The primary central nervous system lymphoma study measures the proportion of participants whose cancer gets worse or who die within 12 months after treatment. This is a practical way to see whether the treatment can help control disease during the first year after therapy.
In the aggressive large B-cell lymphoma studies, one endpoint is complete metabolic response at 3 months after anti-CD19 CAR-T infusion, and another is complete response rate at the end of treatment. A complete response means no clear signs of active cancer are found on study testing.
The long-term follow-up study measures delayed adverse events, persistence of gene-modified T-cell products, vector integration sites, replication competent lentivirus, overall survival, and whether participants progress on study. For younger participants, it also tracks physical growth and sexual maturity until Tanner stage 5 is reached.
The VESICANS study measures endothelial extracellular vesicles, which are tiny particles released by cells, and studies how they change before and after CAR-T treatment according to ICANS grade. This is a more laboratory-based study that helps researchers understand treatment-related neurotoxicity, or nerve system side effects.
Notable studies in the data
NCT04245839 is a Phase 2 study in 232 adults with relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma, and its main goal is to evaluate efficacy and safety. The primary endpoint is overall response rate measured by imaging and the Lugano Classification.
NCT07015242 is a Phase 2 study in 55 adults with newly diagnosed primary central nervous system lymphoma who cannot have autologous stem cell transplant. It looks at whether the cancer worsens or the patient dies within 12 months after receiving Lisocabtagene Maraleucel.
NCT03435796 is a long-term Phase 4 follow-up study with 1,410 participants who previously received gene-modified T-cell therapy, including Lisocabtagene Maraleucel. It is designed to watch for delayed safety issues and long-term outcomes for many years after treatment.
2023-506705-20-00 and 2025-523806-34-00 are Phase 2 studies in aggressive or relapsed/refractory large B-cell lymphoma, with endpoints focused on response after CAR-T-based treatment strategies. These trials help show how Lisocabtagene Maraleucel is being studied in difficult lymphoma settings where relapse risk is high.
2024-515328-35-00 is a Phase 3 hematology study focused on extracellular vesicles and ICANS during CAR-T therapy, with a total enrollment of 60. While not centered only on Lisocabtagene Maraleucel, it is part of the broader CAR-T research landscape in the source data.
Patient-focused takeaways
These trials show that Lisocabtagene Maraleucel is being studied mainly in lymphoma, especially cases that are hard to treat or have returned after earlier therapy.
The research is not only about short-term tumor response, but also about long-term safety, survival, and recovery after treatment. Some studies also look at special groups such as people who cannot have transplant and younger participants who need growth follow-up.
Because the trials use different phases and different endpoints, they answer different questions: does the treatment work, how long does it work, and what happens over time after treatment.