Clinical trial · Interventional
Phase II Trial to Evaluate an EBV-derived Dendritic Cell Vaccine in Autologous Stem Cell Transplant
A Randomized Phase II Trial to Evaluate an EBV Derived Dendritic Cell (DC) Vaccine When Administered Alone or Co-administered With the TLR9 Agonist, DUK-CPG-001, in EBV+ Lymphoma in the Setting of Autologous Stem Cell Transplant
- 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)
This is a non-blinded, not placebo controlled, randomized, parallel phase 2 pilot study to evaluate the immunological response and the safety of Epstein Barr Virus (EBV)-derived tumor antigen, Latent Membrane Protein-2 (LMP2)-loaded dendritic cell (DC) vaccines alone or co-administered with the TLR9 ligand, DUK-CPG-001, in patients with EBV+ lymphoma in the setting of autologous stem cell transplant with infusion of mature T cells. Patients will be randomized to receive vaccine alone or vaccine co-administered with the TLR9 ligand, DUK-CPG-001. Randomization will be stratified by 2 disease types: Hodgkin lymphoma and non-Hodgkin lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DUK-CPG-001 | Biological | — | UNRESOLVED |
| LMP2A-loaded conventional DC vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LMP2A-loaded conventional DC vaccine
- description
- Epstein-Barr virus (EBV) derived tumor antigen, LMP2 loaded DC vaccine
- interventionNames
- Biological: LMP2A-loaded conventional DC vaccine
- type
- EXPERIMENTAL
- label
- LMP2A-loaded DC vaccine + DUK-CPG-001
- description
- Epstein-Barr virus (EBV) derived tumor antigen, LMP2 loaded DC vaccine co-administered with a Toll-like receptor 9 (TLR9) ligand, DUK-CPG-001
- interventionNames
- Biological: DUK-CPG-001
Primary outcomes (1)
- measure
- Immune response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Each patient must meet all of the following inclusion criteria: * Patient must have a histologically proven diagnosis of any EBV+ Hodgkin or non-Hodgkin lymphoma * EBV positive will be defined as positive if LMP1 or 2 or EBER are positive. As long as EBV positive on a prior biopsy, EBV testing will not be required at the time of relapse. However, if EBV testing performed on a more recent biopsy and it is negative, that patient will be excluded. * Patients must have had persistent, relapsed, or refractory disease to at least one prior regimen with plans to proceed to autologous stem cell transplant * Patients must be in a complete remission at time of initial pheresis for vaccine preparation; complete remission will be determined using Cheson Criteria100 * There are no limits on the number of prior therapies allowed * Able to give voluntary written informed consent * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study therapy and for 3 months after vaccine #2. * Male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 3 months after vaccine #2. * Patients must be 18 years of age or older. * ECOG performance status 0-2. Exclusion Criteria * An estimated or measured creatinine clearance of less than 30 ml/min. * AST, ALT, total bilirubin \> 3 times the upper limit of normal * Patients on chronic immunosuppressive therapy for any reason (other than chemotherapy for HL) * Chronic systemic steroid therapy at doses greater than 10mg/day of prednisone or its equivalent. * Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result within 48 hours of enrollment. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Patient has received other investigational drugs for this disease within 14 days of enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Patients who are HIV positive AND have a CD4 count \<50 * Prior solid organ transplant or allogeneic stem cell transplant
References
Publications (0)
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