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

Phase 1

• Conditions: Chronic Lymphocytic Leukemia (CLL); Mantle Cell Lymphoma (MCL); Small Lymphocytic Lymphoma (SLL); Relapsed/Refractory B-cell Lymphomas; Primary Mediastinal Large B Cell Lymphoma; Lymphoplasmacytic Lymphoma; Burkitt Lymphoma; Diffuse Large B-Cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Marginal Zone Lymphoma (MZL)
• Interventions: Combination Product: CLBR001 and SWI019

• Registration Number: NCT04488354
• Lead Sponsor: Calibr, a division of Scripps Research

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-28
• Study Start: 2021-01-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2036-08
• Study Completion: 2036-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

• There are no specific exclusion criteria for this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLBR001 treated patients	CLBR001 and SWI019	Patients who have been administered with CLBR001

Primary Outcome Measures

Name	Time	Method
Incidence and duration of new adverse events, late onset adverse events, and events of special interest	15 years	To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest
Incidence and duration of new serious adverse events	15 years	To measure the incidence and duration of new serious adverse events
Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001	15 years	The measure the incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001
Incidence of new malignancies	15 years	The measure the incidence of new malignancies

Secondary Outcome Measures

Name	Time	Method
Titer of anti-drug antibody (ADA) for CLBR001 and SWI019	3, 6, 12 months	To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019
Proportion of patients undergoing stem cell transplant	15 years	To evaluate the proportion of patients undergoing stem cell transplant
Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens	3, 6, 9,12 and 24 months	To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
Duration of response	15 years	To evaluate clinical efficacy by measuring the duration of response
Progression free survival	15 years	To evaluate clinical efficacy by measuring progression free survival
Overall response	15 years	To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017
Duration of detection of ADA for CLBR001 and SWI019	3, 6, 12 months	To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019
Detectable replication competent lentivirus (RCL)	15 years	To measure detectable replication competent lentivirus (RCL)

Trial Locations

Locations (8)

City of Hope National Medical Center; 🇺🇸 Duarte, California, 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

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

Sarah Cannon Research Institute - Texas Transplant Institute; 🇺🇸 San Antonio, Texas, United States