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Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE1

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

NCT04488354•Calibr, a division of Scripps Research

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (8)

City of Hope National Medical Center

Duarte, California, United States

University of California at San Diego

San Diego, California, United States

University of Chicago

Chicago, Illinois, United States

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, United States

Sarah Cannon Research Institute - Texas Transplant Institute

San Antonio, Texas, United States

Key Dates

Start Date

January 21, 2021

Primary Completion Date

August 1, 2036

Completion Date

August 1, 2036

Last Updated

January 10, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory B-cell LymphomasDiffuse 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 LymphomaTransformed Follicular LymphomaWaldenstrom MacroglobulinemiaLymphoplasmacytic LymphomaBurkitt Lymphoma

Interventions

CLBR001 and SWI019

COMBINATION_PRODUCT

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

NCT06191744

Follicular Lymphoma (FL)

View study

RECRUITING

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

NCT06043011

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Karyopharm Expanded Access Program for Selinexor

Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma