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Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT04642937
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
OX2 Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Treatment with hP1A8 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: hP1A8
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.
 Drug: Treatment with hP1A8
Treatment with hP1A8


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Incidence of serious adverse events (SAEs) [ Time Frame: 12 months ]
  2. Time to progression (TTP) [ Time Frame: 24 months ]
  3. Progression free survival (PFS) [ Time Frame: 24 months ]
  4. Overall survival (OS) [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642937


Contacts
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Contact: Elizabeth Neil, MD 612-625-1969 neile@umn.edu
Contact: Masonic Cancer Center Cancer information nurse line 612-624-2620 ccinfo@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Elizabeth Neil, MD    612-625-1969    neile@umn.edu   
Sponsors and Collaborators
OX2 Therapeutics
More Information
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Responsible Party: OX2 Therapeutics
ClinicalTrials.gov Identifier: NCT04642937    
Other Study ID Numbers: CRPC #2017LS096
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue