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

March 14, 2024 updated by: Calibr, a division of Scripps Research

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • San Diego, California, United States, 92093
        • University of California at San Diego
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center, University of Minnesota
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College - New York Presbyterian Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute - Tennessee Oncology
    • Texas
      • San Antonio, Texas, United States, 78229
        • Sarah Cannon Research Institute - Texas Transplant Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • There are no specific exclusion criteria for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLBR001 treated patients
Patients who have been administered with CLBR001
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calibr, a division of Scripps Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Estimated)

August 1, 2036

Study Completion (Estimated)

August 1, 2036

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBR-sCAR19-3002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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