Relapsed/Refractory B-cell LymphomasPhase 1NCT04488354
Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T
A Phase 1 study testing CLBR001 and SWI019 in people with Relapsed/Refractory B-cell Lymphomas and Diffuse Large B-Cell Lymphoma (DLBCL), run by Calibr, a division of Scripps Research at 8 sites in United States.
Trial summary
This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory B-cell Lymphomas, Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL)
- What is being tested?
- CLBR001 and SWI019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 Jan 2021to 6 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- There are no specific exclusion criteria for this study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Chicago
Chicago, Illinois, 60637
City of Hope National Medical Center
Duarte, California, 91010
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065
Sarah Cannon Research Institute - Texas Transplant Institute
San Antonio, Texas, 78229
University of California at San Diego
San Diego, California, 92093
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: 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
Read the 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.
- Conditions
- Relapsed/Refractory B-cell Lymphomas, Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL)
- Being tested
- CLBR001 and SWI019
- Keywords
- CAR-T Cell Therapy, Switchable CAR-T Cell, Autologous Cell Therapy, CD19 Positive Disease, Blood Cancer, Hematological malignancy, Neoplasms, CD19 CAR-T Cell, Long Term Follow Up (LTFU)
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLBR001 and SWI019Combination product
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
| Study group | Role | What they receive |
|---|---|---|
| CLBR001 treated patients | Experimental | Patients who have been administered with CLBR001 Receives: Combination Product: CLBR001 and SWI019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 years
Incidence and duration of new serious adverse events
To measure the incidence and duration of new serious adverse events
Measured: 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
Measured: 15 years
Incidence of new malignancies
The measure the incidence of new malignancies
Measured: 15 years
Secondary outcomes (8)
Overall response
To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017
Measured: 15 years
Duration of response
To evaluate clinical efficacy by measuring the duration of response
Measured: 15 years
Progression free survival
To evaluate clinical efficacy by measuring progression free survival
Measured: 15 years
Proportion of patients undergoing stem cell transplant
To evaluate the proportion of patients undergoing stem cell transplant
Measured: 15 years
Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
Measured: 3, 6, 9,12 and 24 months
Detectable replication competent lentivirus (RCL)
To measure detectable replication competent lentivirus (RCL)
Measured: 15 years
Titer of anti-drug antibody (ADA) for CLBR001 and SWI019
To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019
Measured: 3, 6, 12 months
Duration of detection of ADA for CLBR001 and SWI019
To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start21 Jan 2021
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory B-cell LymphomasStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calibr, a division of Scripps Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488354
- Sponsor's protocol ID
- CBR-sCAR19-3002
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26759369Viaud 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.
PubMed 30373813
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 Patients With B-Cell Malignancies Previously Administered CLBR001
- ClinicalTrials.gov ID
- NCT04488354
- Acronym / sponsor ID
- CBR-sCAR19-3002
- Conditions
- Relapsed/Refractory B-cell Lymphomas, Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL)
- Keywords
- CAR-T Cell Therapy, Switchable CAR-T Cell, Autologous Cell Therapy, CD19 Positive Disease, Blood Cancer, Hematological malignancy, Neoplasms, CD19 CAR-T Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Calibr, a division of Scripps ResearchUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 28 Jul 2020 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLBR001 treated patients | Experimental | Combination Product: CLBR001 and SWI019Patients who have been administered with CLBR001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study
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 |
|---|---|---|
| CLBR001 and SWI019No 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 | Combination product | CLBR001 treated patients |
Primary outcome
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
Incidence and duration of new serious adverse events
Time frame: 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
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
Incidence of new malignancies
Time frame: 15 years
The measure the incidence of new malignancies
8 secondary outcomes
Overall response
Time frame: 15 years
Duration of response
Time frame: 15 years
Progression free survival
Time frame: 15 years
Proportion of patients undergoing stem cell transplant
Time frame: 15 years
Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
Time frame: 3, 6, 9,12 and 24 months
Detectable replication competent lentivirus (RCL)
Time frame: 15 years
Titer of anti-drug antibody (ADA) for CLBR001 and SWI019
Time frame: 3, 6, 12 months
Duration of detection of ADA for CLBR001 and SWI019
Time frame: 3, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 26759369Rodgers 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.
- Background: PubMed 30373813Viaud 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLBR001 and SWI019 in people with Relapsed/Refractory B-cell Lymphomas and Diffuse Large B-Cell Lymphoma (DLBCL), run by Calibr, a division of Scripps Research at 8 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 3 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: finished, 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 8 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and duration of new adverse events, late onset adverse events, and events of special interest (time frame: 15 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488354, which also lists 2 linked publications.
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.