Trial | NCT04642937  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    24
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.
Study Started
Dec 01
2020
Primary Completion
Nov 30
2023
Anticipated
Study Completion
Nov 30
2024
Anticipated
Last Update
Jan 27
2023

Drug Treatment with hP1A8

Treatment with hP1A8

hP1A8 Experimental

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.

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).
No Results Posted