NCT04488354

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

A Study to Evaluate the Long-Term Safety of CLBR001, A Lentiviral Based Chimeric Antigen Receptor, In Patients With B-Cell Malignancies Previously Administered CLBR001

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells

Detailed description

Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.

Conditions

• Relapsed/Refractory B-cell Lymphomas
• Diffuse Large B-Cell Lymphoma (DLBCL)
• Follicular Lymphoma (FL)
• Chronic Lymphocytic Leukemia (CLL)
• Marginal Zone Lymphoma (MZL)
• Mantle Cell Lymphoma (MCL)
• Small Lymphocytic Lymphoma (SLL)
• Primary Mediastinal Large B Cell Lymphoma
• Transformed Follicular Lymphoma
• Waldenstrom Macroglobulinemia
• Lymphoplasmacytic Lymphoma
• Burkitt Lymphoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CLBR001 and SWI019	No study drug is administered in this study. Patients who have received CLBR001 autologous CAR-T cells will be evaluated in this trial for long-term safety and efficacy

Timeline

• Start date: 2021-01-21
• Primary completion: 2025-10-06
• Completion: 2025-10-06
• First posted: 2020-07-28
• Last updated: 2026-04-08

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study