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Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma

Primary Purpose

Follicular Lymphoma

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

PD-L2 peptide

PD-L2 and PD-L1 peptide

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring PD-L1, PD-L2, peptide vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Herlev Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

3 vaccines of PD-L2 peptide followed by 12 vaccines of PD-L2 and PD-L1 peptide, over the course of one year.

Outcomes

Primary Outcome Measures

Adverse events evaluated by CTCAE 4.03

Adverse events are graded 1-5 according to the criteria

Secondary Outcome Measures

Immune responses

T-cell cytokine release towards target antigens

Full Information

NCT ID

NCT03381768

First Posted

December 8, 2017

Last Updated

February 23, 2021

Sponsor

Lars Møller Pedersen

1. Study Identification

Unique Protocol Identification Number

NCT03381768

Brief Title

Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma

Official Title

PD-L1 and PD-L2 Peptide Vaccination as Consolidation for Relapsed Follicular Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

December 12, 2017 (Actual)

Primary Completion Date

February 12, 2020 (Actual)

Study Completion Date

February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lars Møller Pedersen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular Lymphoma

Keywords

PD-L1, PD-L2, peptide vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Fixed dose safety study

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

3 vaccines of PD-L2 peptide followed by 12 vaccines of PD-L2 and PD-L1 peptide, over the course of one year.

Intervention Type

Biological

Intervention Name(s)

PD-L2 peptide

Intervention Description

100 ug PD-L2 peptide dissolved in DMSO and water mixed with 500ul montanide.

Intervention Type

Biological

Intervention Name(s)

PD-L2 and PD-L1 peptide

Intervention Description

100 ug PD-L2 peptide and 100ug PD-L1 peptide dissolved in DMSO and water mixed with 500ul montanide.

Primary Outcome Measure Information:

Title

Adverse events evaluated by CTCAE 4.03

Description

Adverse events are graded 1-5 according to the criteria

Time Frame

1 year follow up

Secondary Outcome Measure Information:

Title

Immune responses

Description

T-cell cytokine release towards target antigens

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Clinical response according to Lugano criteria

Description

Changes in tumor size on CT

Time Frame

1 year

Title

Clinical response according to Lugano criteria

Description

Changes in tumor metabolism on PET

Time Frame

1 year

Title

Minimal residual disease

Description

measured by circulating tumor DNA

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uffe Klausen, MD

Organizational Affiliation

Hematological department, Herlev Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herlev Hospital

City

Herlev

State/Province

RegionH

ZIP/Postal Code

2730

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma

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