Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liso-cel · 2 trials · 8 indications
Defined as the time from the date of liso-cel infusion to the date of first documented disease relapse or progression as assessed by the investigator, or death from any cause, whichever occurs first
The percentage of subjects who receive a chimeric antigen receptor (CAR) T-cell infusion after receiving bridging radiation therapy. A one-sided Binomial test will be conducted to assess whether acceptable percentage (\>70% vs \<70%) of patients receive CAR T-cell perfusion after undergoing the radiation therapy.
| Arm | Type | Description |
|---|---|---|
| Liso-cel Administration | EXPERIMENTAL | - |
| Single arm | EXPERIMENTAL | Subjects will receive 4 gray (Gy) radiation in 2 fractions in the bridging period following lymphocyte pheresis, prior to lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T-cell infusion. Post CAR T-cell infusion radiation therapy will be allowed as determined by study investigator but prespecified at time of radiation oncology consultation. |
| Name | Type | Description |
|---|---|---|
| Rituximab | DRUG | Specified dose on specified days |
| Methotrexate | DRUG | Specified dose on specified days |
| Procarbazine | DRUG | Specified dose on specified days |
| Temozolomide | DRUG | Specified dose on specified days |
| Liso-cel | BIOLOGICAL | Specified dose on specified days |
| Fludarabine | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
| Calcium folinate | DRUG | Specified dose on specified days |
| Bridging radiation therapy | RADIATION | Days -20 to -7: Patients will receive 2 fractions of 2 gray (Gy) for a total of 4 Gy received. |
| Post-infusion radiation | RADIATION | Days 30 to 80: Patients eligible for post-infusion radiation will receive a total dose of up to 32 Gy. |
Inclusion Criteria * Participant must be 18 years or older at the time of signing the informed consent form (ICF). * Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology. * Transplant-ineligible based on physician's assess...
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Liso-cel, also known as lisocabtagene maraleucel, is an investigational CD19-directed therapy being studied for the treatment of B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL) and other relapsed or refractory non-Hodgkin lymphomas. It is also being evaluated as a first-line therapy in adults with transplant-ineligible primary central nervous system lymphoma.
Liso-cel targets CD19, a protein expressed on the surface of B cells. It is a binding agent designed to recognize and engage CD19-positive cells, which are implicated in certain B-cell malignancies such as DLBCL and other non-Hodgkin lymphomas.
Liso-cel is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the therapy's safety and efficacy in patients with B-cell lymphomas.
Liso-cel is in clinical development. It is being studied in a Phase 1 trial for relapsed B-cell non-Hodgkin lymphoma and a Phase 2 trial for transplant-ineligible primary central nervous system lymphoma. It is not yet approved by regulatory authorities and remains investigational.
Liso-cel is being evaluated in two active clinical trials. NCT05621096 is a Phase 1 study of low-dose radiation as bridging therapy in relapsed B-cell non-Hodgkin lymphoma, enrolling 33 participants in the United States. NCT07015242 is a Phase 2 study of Liso-cel as first-line therapy in adults with transplant-ineligible primary central nervous system lymphoma, enrolling 65 participants in the United States, France, and Germany.
Yes, Liso-cel is the same as lisocabtagene maraleucel. Liso-cel is a shortened name for the investigational therapy, which is being studied for the treatment of B-cell lymphomas, including DLBCL and primary central nervous system lymphoma.