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

OX2 Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: Glioblastoma

Treatments: Drug: Treatment with hP1A8

Study type: Interventional

Funder types: Industry

Identifiers

NCT04642937

CRPC #2017LS096

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 1 patient group

hP1A8

Experimental group

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.

Treatment:

Drug: Treatment with hP1A8