Follicular LymphomaPhase 1NCT03381768
Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma
A Phase 1 study testing PD-L2 peptide and PD-L2 and PD-L1 peptide in people with Follicular Lymphoma, run by Lars Møller Pedersen at 1 site in Denmark.
Trial summary
An open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2) peptides in patients with relapsed follicular lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- PD-L2 peptide and PD-L2 and PD-L1 peptide
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Dec 2017to 12 Feb 2020
- 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
- Histologically documented FL grade I-IIIa, with no sign of current transformation. Patients cured of transformed lymphoma are eligible.
- A minimum of one line of induction therapy. Maintenance rituximab can continue along with the vaccination
- At least partial response to the latest standard treatment
- A minimum of 4 weeks since last treatment
- Age ≥ 18
- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Adequate hematologic and end-organ function
Who cannot join
- Progression with the presence of at least one GELF criteria or transformation at inklusion time.
- Other active malignant diseases
- Significant medical condition per investigators judgement e.g. severe Asthma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.
- Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis
- Serious known allergies or earlier anaphylactic reactions.
- Known sensibility towards Montanide ISA-51
- Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PD-L1 and PD-L2 Peptide Vaccination as Consolidation for Relapsed Follicular Lymphoma
An open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2) peptides in patients with relapsed follicular lymphoma.
Read the detailed description
Follicular lymphoma (FL) is the the most common of the indolent lymphomas, with an incidence in Denmark of 220 per year. In 90% of the cases the disease is incurable why the treatment strategy often is watchful waiting until significant signs of progression or transformation. After chemotherapy, maintenance therapy is often used to increase disease control.
The microenvironment and immune escape mechanism are believed to play a major role in the persistence of the lymphoma. One escape mechanism is the PD-L1 and PD-L2 molecules expressed in the microenvironment of follicular lymphoma inhibiting the T-cells. By stimulating the T-cells to attack PD-L1 and PD-L2 expressing cells we hope to hamper the immunosuppressive tumor environment and establish immune tumor control.
10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.
- Conditions
- Follicular Lymphoma
- Being tested
- PD-L2 peptide, PD-L2 and PD-L1 peptide
- Keywords
- PD-L1, PD-L2, peptide vaccine
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L2 peptideBiological
100 ug PD-L2 peptide dissolved in DMSO and water mixed with 500ul montanide.
PD-L2 and PD-L1 peptideBiological
100 ug PD-L2 peptide and 100ug PD-L1 peptide dissolved in DMSO and water mixed with 500ul montanide.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 3 vaccines of PD-L2 peptide followed by 12 vaccines of PD-L2 and PD-L1 peptide, over the course of one year. Receives: Biological: PD-L2 peptide; Biological: PD-L2 and PD-L1 peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events evaluated by CTCAE 4.03
Adverse events are graded 1-5 according to the criteria
Measured: 1 year follow up
Secondary outcomes (1)
Immune responses
T-cell cytokine release towards target antigens
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start12 Dec 2017
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fixed dose safety study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Møller Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Møller Pedersen, Herlev Hospital
- Investigators
- Uffe Klausen, MD, Principal investigator, Hematological department, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381768
- Sponsor's protocol ID
- FL1701
- Other IDs
- 2017-002000-28, 2017
- Status last verified
- Feb 2021
- First submitted
- 8 Dec 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmstrom MO, Ahmad SM, Klausen U, Bjorn ME, Gang AO, El-Galaly TC, Pedersen LM, Andersen MH. Unusually long remission in two patients with follicular lymphoma receiving immunomodulating therapeutic cancer vaccines. Leuk Res Rep. 2026 Sep 2;26:100604. doi: 10.1016/j.lrr.2026.100604. eCollection 2026.
PubMed 42741091
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-L1 and PD-L2 Peptide Vaccination as Consolidation for Relapsed Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT03381768
- Acronym / sponsor ID
- FL1701
- Conditions
- Follicular Lymphoma
- Keywords
- PD-L1, PD-L2, peptide vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lars Møller PedersenUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 22 Dec 2017 (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.
An open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2) peptides in patients with relapsed follicular lymphoma.
Detailed description
Follicular lymphoma (FL) is the the most common of the indolent lymphomas, with an incidence in Denmark of 220 per year. In 90% of the cases the disease is incurable why the treatment strategy often is watchful waiting until significant signs of progression or transformation. After chemotherapy, maintenance therapy is often used to increase disease control.
The microenvironment and immune escape mechanism are believed to play a major role in the persistence of the lymphoma. One escape mechanism is the PD-L1 and PD-L2 molecules expressed in the microenvironment of follicular lymphoma inhibiting the T-cells. By stimulating the T-cells to attack PD-L1 and PD-L2 expressing cells we hope to hamper the immunosuppressive tumor environment and establish immune tumor control.
10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed dose safety study
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Biological: PD-L2 peptide, Biological: PD-L2 and PD-L1 peptide3 vaccines of PD-L2 peptide followed by 12 vaccines of PD-L2 and PD-L1 peptide, over the course of one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically documented FL grade I-IIIa, with no sign of current transformation. Patients cured of transformed lymphoma are eligible.
- A minimum of one line of induction therapy. Maintenance rituximab can continue along with the vaccination
- At least partial response to the latest standard treatment
- A minimum of 4 weeks since last treatment
- Age ≥ 18
Key exclusion criteria (8 listed)
- Progression with the presence of at least one GELF criteria or transformation at inklusion time.
- Other active malignant diseases
- Significant medical condition per investigators judgement e.g. severe Asthma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.
- Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis
- Serious known allergies or earlier anaphylactic reactions.
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 |
|---|---|---|
| PD-L2 peptide100 ug PD-L2 peptide dissolved in DMSO and water mixed with 500ul montanide. | Biological | Study group |
| PD-L2 and PD-L1 peptide100 ug PD-L2 peptide and 100ug PD-L1 peptide dissolved in DMSO and water mixed with 500ul montanide. | Biological | Study group |
Primary outcome
Adverse events evaluated by CTCAE 4.03
Time frame: 1 year follow up
Adverse events are graded 1-5 according to the criteria
1 secondary outcome
Immune responses
Time frame: 1 year
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 24 Feb 2021.
- Derived from this study: PubMed 42741091Holmstrom MO, Ahmad SM, Klausen U, Bjorn ME, Gang AO, El-Galaly TC, Pedersen LM, Andersen MH. Unusually long remission in two patients with follicular lymphoma receiving immunomodulating therapeutic cancer vaccines. Leuk Res Rep. 2026 Sep 2;26:100604. doi: 10.1016/j.lrr.2026.100604. eCollection 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. This study is not recruiting at the moment.
Uffe Klausen, MD principal investigator
Hematological department, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PD-L2 peptide and PD-L2 and PD-L1 peptide in people with Follicular Lymphoma, run by Lars Møller Pedersen at 1 site in Denmark.
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 8 inclusion and 8 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Adverse events evaluated by CTCAE 4.03 (time frame: 1 year follow up). 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 NCT03381768, which also lists 1 linked publication.
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 24 Feb 2021.