Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 24, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedJanuary 27, 2023
January 1, 2023
2.9 years
November 19, 2020
January 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
12 months
Secondary Outcomes (4)
Incidence of serious adverse events (SAEs)
12 months
Time to progression (TTP)
24 months
Progression free survival (PFS)
24 months
Overall survival (OS)
24 months
Study Arms (1)
hP1A8
EXPERIMENTALUp 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OX2 Therapeuticslead
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
November 24, 2020
Study Start
December 1, 2020
Primary Completion
November 1, 2023
Study Completion
November 1, 2024
Last Updated
January 27, 2023
Record last verified: 2023-01