Long Term Follow-UpNCT06882317
Long Term Follow-up Study for Subjects Administered CLBR001
An observational study of Long Term Follow-Up, run by Calibr, a division of Scripps Research at 3 sites in United States.
Trial summary
The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Follow-Up
- What is being tested?
- Long Term Follow-Up
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Aug 2025to Feb 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who received CLBR001.
Who may be able to join
- Subjects who received at least one CLBR001 cell dose.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22908
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Virtual Research Group- Premier Research
Morrisville, North Carolina, 27560
About this study
Official title: A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies.
Participants will be followed for 15 years post-gene therapy administration date for safety and efficacy.
Read the detailed description
In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.
- Conditions
- Long Term Follow-Up
- Being tested
- Long Term Follow-Up
- Keywords
- Long Term Follow-Up (LTFU), CLBR001, Autologous Cell Therapy, Switchable CAR-T Cell, Cell and Gene Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Term Follow-UpOther
No intervention is administered on this study. Subjects who have received CLBR001 autologous CAR-T cells in a primary Calibr treatment trial will be followed long term in line with FDA guidance.
| Study group | Role | What they receive |
|---|---|---|
| CLBR001 Treated Subjects | Subjects who received CLBR001 on any Calibr treatment study. Receives: Other: Long Term Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as assessed by CTCAE v5.0.
To assess the long term safety of CLBR001 in subjects by evaluating the incidence, duration, and outcome of adverse events (including adverse events of special interest, CLBR001-related adverse events and serious adverse events), as assessed by CTCAE v5.0.
Measured: To 15 years post-CLBR001 administration.
Number of subjects with replication competent lentivirus (RCL).
To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.
Measured: To 15 years post-CLBR001 administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start28 Aug 2025
- Primary completionFeb 2044 (estimated)
- Study completionFeb 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Follow-UpStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calibr, a division of Scripps Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Calibr-Skaggs Institute for Innovative Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882317
- Sponsor's protocol ID
- CBR-CLBR001-3002
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
- ClinicalTrials.gov ID
- NCT06882317
- Acronym / sponsor ID
- CBR-CLBR001-3002
- Conditions
- Long Term Follow-Up
- Keywords
- Long Term Follow-Up (LTFU), CLBR001, Autologous Cell Therapy, Switchable CAR-T Cell, Cell and Gene Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Calibr, a division of Scripps ResearchUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Feb 2044 (estimated)
- Study completion
- Feb 2044 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies.
Participants will be followed for 15 years post-gene therapy administration date for safety and efficacy.
Detailed description
In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLBR001 Treated Subjects | – | Other: Long Term Follow-UpSubjects who received CLBR001 on any Calibr treatment study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who received CLBR001.
Key inclusion criteria (1 listed)
- Subjects who received at least one CLBR001 cell dose.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long Term Follow-UpNo intervention is administered on this study. Subjects who have received CLBR001 autologous CAR-T cells in a primary Calibr treatment trial will be followed long term in line with FDA guidance. | Other | CLBR001 Treated Subjects |
Primary outcome
Number of subjects with adverse events as assessed by CTCAE v5.0.
Time frame: To 15 years post-CLBR001 administration.
To assess the long term safety of CLBR001 in subjects by evaluating the incidence, duration, and outcome of adverse events (including adverse events of special interest, CLBR001-related adverse events and serious adverse events), as assessed by CTCAE v5.0.
Number of subjects with replication competent lentivirus (RCL).
Time frame: To 15 years post-CLBR001 administration.
To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chief Medical Officer study director
Calibr-Skaggs Institute for Innovative Medicines
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Term Follow-Up, run by Calibr, a division of Scripps Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events as assessed by CTCAE v5.0. (time frame: To 15 years post-CLBR001 administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.