CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.
This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.
Age greater than or equal to 18 at the time of enrollment Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care Eastern Cooperative Oncology Group performance status 0 or 1 Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Exclusion Criteria:
Prior therapy with an anti-CD19 targeting agent Active or chronic graft versus host disease requiring therapy Prior allogeneic stem cell transplantation Central nervous system (CNS) lymphoma, prior CNS malignancy Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement. Primary immunodeficiency Current or expected need for systemic corticosteroid therapy Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence Unwillingness to follow extended safety monitoring
