Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lisocabtagene maraleucel · 1 trial · 10 indications
Cytokine release syndrome is characterized by high fever, fatigue, nausea, headache, dyspnea, tachycardia, rigors, hypotension, hypoxia, myalgia/arthralgia, and anorexia. Incidence of Grade ≥ 3 CRS, based on the TEAE with MedDRA PT "Cytokine release syndrome," graded according to the grading scale adapted from Lee (Lee 2014).
NT events have also been reported and may include neurologic symptoms such as altered mental status, aphasia, altered level of consciousness, and seizures or seizure-like activity. Incidence of Grade ≥ 3 NT, defined as an Investigator-identified TEAE considered neurotoxicity related to JCAR017.
Incidence of treatment-emergent Grade ≥ 3 infections, defined using MedDRA SOC.
Prolonged cytopenia is defined as the occurrence of Grade ≥ 3 cytopenia not resolved by the Day 29 visit, based on laboratory results of low hemoglobin, absolute neutrophil count decreased, and platelet count decreased. The frequency of subjects experiencing each individual laboratory abnormality and the total number with at least 1 abnormality will be summarized, as will recovery from prolonged cytopenia after Day 29.
| Arm | Type | Description |
|---|---|---|
| Lisocabtagene maraleucel | EXPERIMENTAL | Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of lisocabtagene maraleucel. During lisocabtagene maraleucel production, subjects may receive low-dose chemotherapy for disease control. Upon successful generation of lisocabtagene maraleucel product, subjects will receive treatment which will include lymphodepleting chemotherapy followed by one dose of lisocabtagene maraleucel administered by intravenous (IV) injection. |
| Name | Type | Description |
|---|---|---|
| lisocabtagene maraleucel | BIOLOGICAL | lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection |
Inclusion Criteria: * Age ≥ 18 years at the time of consent * Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and...
Lisocabtagene maraleucel is used for the treatment of relapsed and refractory B-cell non-Hodgkin lymphoma, including large B-cell lymphoma. It is an investigational therapy being studied in patients with non-Hodgkin lymphoma who have not responded to prior treatment or whose disease has returned.
Lisocabtagene maraleucel targets CD19, a protein found on the surface of B cells. By binding to CD19, the therapy is designed to direct the immune system against malignant B cells involved in non-Hodgkin lymphoma.
Lisocabtagene maraleucel is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this therapy for patients with non-Hodgkin lymphoma.
Lisocabtagene maraleucel is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The therapy is being evaluated in a completed Phase 2 trial for relapsed and refractory B-cell non-Hodgkin lymphoma.
Lisocabtagene maraleucel was studied in clinical trial NCT03744676, titled "A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)." This Phase 2 trial enrolled 104 participants in the United States and has been completed.
Yes, lisocabtagene maraleucel is also known as JCAR017. The clinical trial NCT03744676 refers to the therapy as JCAR017, and it is being studied for the treatment of relapsed and refractory B-cell non-Hodgkin lymphoma.