NCT04637763

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Caribou Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphoma, Non-Hodgkin
• Relapsed Non Hodgkin Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Non Hodgkin Lymphoma
• Lymphoma
• B Cell Lymphoma
• B Cell Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
GENETIC	CB-010	CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
DRUG	Cyclophosphamide	Chemotherapy for lymphodepletion
DRUG	Fludarabine	Chemotherapy for lymphodepletion

Timeline

• Start date: 2021-05-26
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2020-11-20
• Last updated: 2025-03-24

Locations

38 sites across 3 countries: United States, Australia, Israel

Regulatory

• FDA-regulated drug study