Overview
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.
Principal investigator
Eligibility criteria
Inclusion Criteria:
- 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
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