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NCT04642937 Clinical Trial

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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04642937
Other study ID # CRPC #2017LS096
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2020
Est. completion date November 2024

Study information
Verified date January 2023
Source OX2 Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 24
Est. completion date November 2024
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment with hP1A8
Treatment with hP1A8

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
OX2 Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD 12 months
Secondary Incidence of serious adverse events (SAEs) 12 months
Secondary Time to progression (TTP) 24 months
Secondary Progression free survival (PFS) 24 months
Secondary Overall survival (OS) 24 months
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