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Lisocabtagene Maraleucel · 1 trial · 8 indications
Overall response rate (ORR) will be defined as the proportion of patients achieving a complete or partial response divided by the number of efficacy-evaluable patients according to the Revised Response Criteria for Malignant Lymphoma. Response will be assessed using Lugano criteria 2014. ORR will be reported with two-sided 95% and 80% binomial exact confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Treatment (zanubrutinib, liso-cel) | EXPERIMENTAL | Patients receive zanubrutinib PO BID for up to day 90 and undergo leukaphereis at least 14 days after starting zanubrutinib. Patients receive fludarabine IV and cyclophosphamide IV on days -5 to -3 and liso-cel IV over 5-30 minutes on day 0. Patients also undergo BM biopsy and lymph node biopsy at screening and follow up, and undergo collection of blood samples and CT, PET/CT, and/or MRI throughout the trial. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo collection of blood samples |
| Bone Marrow Biopsy | PROCEDURE | Undergo BM biopsy |
| Computed Tomography | PROCEDURE | Undergo CT and/or PET/CT |
| Cyclophosphamide | DRUG | Given IV |
| Fludarabine | DRUG | Given IV |
| Leukapheresis | PROCEDURE | Given IV |
| Lisocabtagene Maraleucel | BIOLOGICAL | Given IV |
| Lymph Node Biopsy | PROCEDURE | Undergo lymph node biopsy |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Zanubrutinib | DRUG | Given PO |
Inclusion Criteria: * Diagnosis of RS - occurrence of diffuse large B-cell lymphoma (DLBCL) in patients with antecedent or concurrent CLL/SLL (CLL/SLL diagnosis per IWCLL 2018 criteria). * Must have relapsed/refractory disease as defined by one of the following: * Participants must have undergon...
Lisocabtagene Maraleucel is being studied for the treatment of recurrent transformed chronic lymphocytic leukemia, including transformed chronic lymphocytic leukemia to diffuse large B-cell lymphoma, as well as recurrent and refractory transformed B-cell non-Hodgkin lymphoma. It is an investigational cell therapy currently in Phase 2 clinical development.
Lisocabtagene Maraleucel is a cell therapy, classified under the -cel (cell tx) target class. It is being evaluated in combination with zanubrutinib for the treatment of Richter's syndrome, which includes recurrent transformed chronic lymphocytic leukemia. The therapy is designed to target and eliminate cancerous B cells.
Lisocabtagene Maraleucel is being developed by BeOne Medicines Ltd., a company traded under the ticker ONC. The drug is currently in Phase 2 clinical development for recurrent transformed chronic lymphocytic leukemia and related conditions.
Lisocabtagene Maraleucel is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It is currently being studied in an active clinical trial for recurrent transformed chronic lymphocytic leukemia and related conditions.
Lisocabtagene Maraleucel is being studied in clinical trial NCT05873712, titled 'Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome.' This Phase 2 trial is recruiting 24 participants in the United States and is not randomized or blinded.
Lisocabtagene Maraleucel is also known as liso-cel, a CD19-directed chimeric antigen receptor T-cell therapy. In the context of this clinical trial, it is being evaluated in combination with zanubrutinib for the treatment of Richter's syndrome, which includes recurrent transformed chronic lymphocytic leukemia.