Paolo Caimi, MD
CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL/SLL, possibly secondary to the suppressive effect of circulating B cells on T cell function. BAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.
There is a persistent need for development of new, effective therapies for treatment of B cell malignancies. Therapy with CAR-T cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. While CAR T-cells have activity against CLL/SLL, the rates of response are more limited than non Hodgkin lymphoma. Based on preclinical data of anti BAFF-R CAR T-cells13 as well as preclinical and early phase studies using anti-BAFF-R monoclonal antibodies in CLL) investigators posit that CAR-T cells expressing BAFF (BAFF CAR-…
Inclusion Criteria: 1. Histologically confirmed chronic lymphocytic leukemia (including small lymphocytic lymphoma) * Relapsed after 2 or more lines of therapy, including a BTK inhibitor and a BCL2 inhibitor. 2. No evidence of CNS lymphoma. 3. Male or female ≥ 18 years of age. 4. ECOG Performance status ≤ 2 \[See Appendix 1\]. 5. Presence of Presence of active disease for participants with CLL and SLL and presence of measurable disease for participants with SLL. A. CLL/SLL (note that SLL participants must have both measurable disease and active disease): Active disease as defined by t…
Single infusion
IV administered
500mg/m2 on days -5 to -3
30mg/m2 daily on days -5 to -3
Arctuva estimate
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