Back to resultsStudy of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
Primary Purpose
Glioblastoma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment with hP1A8
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma
Eligibility Criteria
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).
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hP1A8
Arm 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.
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
Secondary Outcome Measures
Incidence of serious adverse events (SAEs)
Time to progression (TTP)
Progression free survival (PFS)
Overall survival (OS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04642937
Brief Title
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
Official Title
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OX2 Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hP1A8
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Treatment with hP1A8
Intervention Description
Treatment with hP1A8
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of serious adverse events (SAEs)
Time Frame
12 months
Title
Time to progression (TTP)
Time Frame
24 months
Title
Progression free survival (PFS)
Time Frame
24 months
Title
Overall survival (OS)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
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