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

Calibr, a division of Scripps Research

Status and phase

Invitation-only

Phase 1

Conditions

Waldenstrom Macroglobulinemia

Lymphoplasmacytic Lymphoma

Relapsed/Refractory B-cell Lymphomas

Primary Mediastinal Large B Cell Lymphoma

Small Lymphocytic Lymphoma (SLL)

Marginal Zone Lymphoma (MZL)

Diffuse Large B-Cell Lymphoma (DLBCL)

Follicular Lymphoma (FL)

Mantle Cell Lymphoma (MCL)

Transformed Follicular Lymphoma

Burkitt Lymphoma

Chronic Lymphocytic Leukemia (CLL)

Treatments

Combination Product: CLBR001 and SWI019

Study type

Interventional

Funder types

Other

Identifiers

NCT04488354

CBR-sCAR19-3002

Details and patient eligibility

About

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

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion criteria