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.
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.
No evidence of CNS lymphoma.
Male or female ≥ 18 years of age.
ASCT within 6 weeks of informed consent.
History of allogeneic hematopoietic stem cell transplantation.
Active graft-versus-host disease.
Active central nervous system or meningeal involvement by lymphoma or leukemia. Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.
Sequential
BAFF CAR-T
DrugSingle infusion
Obinutuzumab
DrugIV administered
Cyclophosphamide
Drug500mg/m2 on days -5 to -3
Fludarabine
Drug30mg/m2 daily on days -5 to -3
Maximum tolerated dose of LMY-920
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Objective response rate(ORR)
Complete response rate(CRR)
Duration of response(DOR) rate
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Paolo Caimi, MD
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
The Leukemia and Lymphoma Society
Collaborator
