Clinical trial · Interventional
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
NCT04642937CI-TRIAL-00063498unknownPhase 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)
This is a single-center, open-label, dose-range finding Phase I study of hP1A8, a new adjuvant CD200 activation receptor ligand (CD200AR-L), in combination with imiquimod and the GBM6-AD vaccine to treat recurrent glioblastoma (GBM) in adults.
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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment with hP1A8 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hP1A8
- description
- Up to 3 dose levels of hP1A8 will be tested with a Dose Level -1 in the event of toxicity. The MTD will be identified using the standard 3+3 design. Upon determination of the MTD, additional patients will be enrolled as part of an expansion cohort.
- interventionNames
- Drug: Treatment with hP1A8
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
- timeFrame
- 12 months
Secondary outcomes (4)
- measure
- Incidence of serious adverse events (SAEs)
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years and older. * Confirmed diagnosis of GBM. * Radiographically or histologically proven progression or recurrence of disease at any time after standard of care therapy (radiation, temozolomide, with or without a tumor treatment field device). * Tumor debulking or biopsies may be performed to clinical trial enrollment if indicated and feasible. Exclusion Criteria: * Bevacizumab or targeted therapy within 45 days of enrollment. * Intercurrent immune system disorder such as hypoimmunity (marrow failure, HIV) or hyperimmunity (autoimmune disease). * Unable to complete a standard upfront course of chemoradiotherapy due to disease progression or intolerance of therapy. * History of Gliadel water, GammaTile or other implanted therapeutic agent. * Concurrent use of tumor treatment field devices (e.g. Optune).
References
Publications (0)
Data not yet available
No reference posted for this study.