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
1 other identifier
interventional
16
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2021
Longer than P75 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedStudy Start
First participant enrolled
January 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2025
CompletedApril 8, 2026
April 1, 2026
4.7 years
July 20, 2020
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence and duration of new adverse events, late onset adverse events, and events of special interest
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
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
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
The measure the incidence of new malignancies
15 years
Secondary Outcomes (8)
Overall response
15 years
Duration of response
15 years
Progression free survival
15 years
Proportion of patients undergoing stem cell transplant
15 years
Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
3, 6, 9,12 and 24 months
- +3 more secondary outcomes
Study Arms (1)
CLBR001 treated patients
EXPERIMENTALPatients who have been administered with CLBR001
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California at San Diego
San Diego, California, 92093, United States
University of Chicago
Chicago, Illinois, 60637, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute - Texas Transplant Institute
San Antonio, Texas, 78229, United States
Related Publications (2)
Rodgers DT, Mazagova M, Hampton EN, Cao Y, Ramadoss NS, Hardy IR, Schulman A, Du J, Wang F, Singer O, Ma J, Nunez V, Shen J, Woods AK, Wright TM, Schultz PG, Kim CH, Young TS. Switch-mediated activation and retargeting of CAR-T cells for B-cell malignancies. Proc Natl Acad Sci U S A. 2016 Jan 26;113(4):E459-68. doi: 10.1073/pnas.1524155113. Epub 2016 Jan 12.
PMID: 26759369BACKGROUNDViaud S, Ma JSY, Hardy IR, Hampton EN, Benish B, Sherwood L, Nunez V, Ackerman CJ, Khialeeva E, Weglarz M, Lee SC, Woods AK, Young TS. Switchable control over in vivo CAR T expansion, B cell depletion, and induction of memory. Proc Natl Acad Sci U S A. 2018 Nov 13;115(46):E10898-E10906. doi: 10.1073/pnas.1810060115. Epub 2018 Oct 29.
PMID: 30373813BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 28, 2020
Study Start
January 21, 2021
Primary Completion
October 6, 2025
Study Completion
October 6, 2025
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share