Clinical Trials /

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

NCT04642937

Description:

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.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CRPC #2017LS096
  • NCT ID: NCT04642937

Conditions

  • Glioblastoma

Interventions

DrugSynonymsArms
Treatment with hP1A8hP1A8

Purpose

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 Arms

NameTypeDescriptionInterventions
hP1A8ExperimentalUp 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.
  • Treatment with hP1A8

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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD
Time Frame:12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of serious adverse events (SAEs)
Time Frame:12 months
Safety Issue:
Description:
Measure:Time to progression (TTP)
Time Frame:24 months
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:24 months
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:OX2 Therapeutics

Last Updated

November 25, 2020