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)
Caribou Biosciences, Inc.
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, cerebrovascul…
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)
- University of Alabama at BirminghamBirmingham, Alabama
- Banner MD Anderson Cancer CenterGilbert, Arizona
- HonorHealthScottsdale, Arizona
- University of Arizona Cancer CenterTucson, Arizona
- University of ArkansasLittle Rock, Arkansas
- University of California San Diego Moores Cancer CenterLa Jolla, California