Clinical trial · Interventional
Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma
PD-L1 and PD-L2 Peptide Vaccination as Consolidation for Relapsed Follicular Lymphoma
NCT03381768CI-TRIAL-00050295completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-L2 and PD-L1 peptide | Biological | — | UNRESOLVED |
| PD-L2 peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- 3 vaccines of PD-L2 peptide followed by 12 vaccines of PD-L2 and PD-L1 peptide, over the course of one year.
- interventionNames
- Biological: PD-L2 peptide
- Biological: PD-L2 and PD-L1 peptide
Primary outcomes (1)
- measure
- Adverse events evaluated by CTCAE 4.03
- timeFrame
- 1 year follow up
- description
- Adverse events are graded 1-5 according to the criteria
Secondary outcomes (1)
- measure
- Immune responses
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.