RecruitingPhase 1NCT04637763
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
Sponsor
Caribou Biosciences, Inc.
Enrollment
72 participants
Start Date
May 26, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria10
- 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
Interventions
GENETICCB-010
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
DRUGCyclophosphamide
Chemotherapy for lymphodepletion
DRUGFludarabine
Chemotherapy for lymphodepletion
Locations(38)
View Full Details on ClinicalTrials.gov
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NCT04637763
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