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CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT04637763.