CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Caribou Biosciences, Inc.
• Treatments: Cyclophosphamide; Fludarabine

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