Hematological MalignanciesPhase 3HesperiaNCT06652633
Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
A Phase 3 study testing GLPG CAR T-cell therapy in people with Hematological Malignancies, run by Lakefront Biotherapeutics NV at 11 sites in 5 countries.
Trial summary
This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion. Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- GLPG CAR T-cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 9 Sep 2024to Jul 2039
- Phase
- Phase 3
- 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
Who may be able to join
- All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.
Who cannot join
- There are no exclusion criteria for this study
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
Belgium5 sites, 5 recruiting
- Recruiting
Antwerp University Hospital
Edegem, 2650
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
- Recruiting
Centre Hospitalier Universitaire (CHU) De Liège
Liège, 4032
- Recruiting
Algemeen Ziekenhuis Delta
Roeselare, 8800
- Recruiting
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200
Netherlands3 sites, 3 recruiting
- Recruiting
Academisch Medisch Centrum (Amsterdam UMC)
Amsterdam, 1105 AZ
- Recruiting
Leids University Medical Center (LUMC)
Leiden, 2333 ZA
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Finland1 site, 1 recruiting
- Recruiting
helsingin yliopistollinen sairaala comprehensive cancer center (HUS)
Helsinki, 00290
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic De Barcelona
Barcelona, 08036
About this study
Official title: A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies
This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.
- Conditions
- Hematological Malignancies
- Being tested
- GLPG CAR T-cell therapy
- Keywords
- CAR T-cell therapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG CAR T-cell therapyGenetic
No investigational products will be administered to participants in this study.
| Study group | Role | What they receive |
|---|---|---|
| Previously treated participants with GLPG CAR T-cell therapy | Experimental | All participants who have been treated with a Galapagos CAR T-cell therapy Receives: Genetic: GLPG CAR T-cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with targeted adverse events (AEs)
Measured: From infusion up to 15 years
Percentage of participants with detectable CAR transgene levels in peripheral blood
Measured: From infusion up to 15 years
Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy
Measured: From infusion up to 15 years
Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies
Measured: From infusion up to 15 years
Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood
Measured: From infusion up to 15 years
Percentage of participants who died with causes
Measured: From infusion up to 15 years
Secondary outcomes (3)
Percentage of participants with disease progression
Measured: From infusion up to 15 years
Time to subsequent anticancer therapy
Measured: From infusion up to 15 years
Overall survival
Measured: From infusion up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start9 Sep 2024
- Primary completionJul 2039 (estimated)
- Study completionJul 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies 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 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lakefront Biotherapeutics Study Director, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652633
- Sponsor's protocol ID
- LTF-CL-001
- Other IDs
- 2023-510173-34-00, 2023
- Acronym
- Hesperia
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies
- ClinicalTrials.gov ID
- NCT06652633
- Acronym / sponsor ID
- Hesperia / LTF-CL-001
- Conditions
- Hematological Malignancies
- Keywords
- CAR T-cell therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Jul 2039 (estimated)
- Study completion
- Jul 2039 (estimated)
- First posted
- 22 Oct 2024 (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 is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previously treated participants with GLPG CAR T-cell therapy | Experimental | Genetic: GLPG CAR T-cell therapyAll participants who have been treated with a Galapagos CAR T-cell therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.
Key exclusion criteria (1 listed)
- There are no 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 |
|---|---|---|
| GLPG CAR T-cell therapyNo investigational products will be administered to participants in this study. | Genetic | Previously treated participants with GLPG CAR T-cell therapy |
Primary outcome
Percentage of participants with targeted adverse events (AEs)
Time frame: From infusion up to 15 years
Percentage of participants with detectable CAR transgene levels in peripheral blood
Time frame: From infusion up to 15 years
Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy
Time frame: From infusion up to 15 years
Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies
Time frame: From infusion up to 15 years
Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood
Time frame: From infusion up to 15 years
Percentage of participants who died with causes
Time frame: From infusion up to 15 years
3 secondary outcomes
Percentage of participants with disease progression
Time frame: From infusion up to 15 years
Time to subsequent anticancer therapy
Time frame: From infusion up to 15 years
Overall survival
Time frame: From infusion up to 15 years
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 13 Jul 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.
Lakefront Biotherapeutics Study Director study director
Lakefront Biotherapeutics NV
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GLPG CAR T-cell therapy in people with Hematological Malignancies, run by Lakefront Biotherapeutics NV at 11 sites in 5 countries.
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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium, Netherlands, United States, Finland, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lakefront Biotherapeutics Medical Information (+3215342900, medicalinfo@lakefrontbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with targeted adverse events (AEs) (time frame: From infusion up to 15 years). The study lists 6 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 13 Jul 2026.