NCT03381768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

December 12, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

December 8, 2017

Last Update Submit

February 23, 2021

Conditions

Follicular Lymphoma

Keywords

PD-L1PD-L2peptide vaccine

Outcome Measures

Primary Outcomes (1)

  • Adverse events evaluated by CTCAE 4.03

    Adverse events are graded 1-5 according to the criteria

    1 year follow up

Secondary Outcomes (1)

  • Immune responses

    1 year

Other Outcomes (3)

  • Clinical response according to Lugano criteria

    1 year

  • Clinical response according to Lugano criteria

    1 year

  • Minimal residual disease

    1 year

Study Arms (1)

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.

Biological: PD-L2 peptideBiological: PD-L2 and PD-L1 peptide

Interventions

PD-L2 peptideBIOLOGICAL

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

Study group
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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, RegionH, 2730, Denmark

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Programmed Cell Death 1 Ligand 2 Protein

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune Checkpoint ProteinsProteinsAmino Acids, Peptides, and ProteinsB7 AntigensIntercellular Signaling Peptides and ProteinsMembrane ProteinsAntigens, SurfaceAntigensBiological Factors

Study Officials

  • Uffe Klausen, MD

    Hematological department, Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Fixed dose safety study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief consultant

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 22, 2017

Study Start

December 12, 2017

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)