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

Phase 1

Active, not recruiting

• Conditions: Glioblastoma
• Interventions: Drug: Treatment with hP1A8

• Registration Number: NCT04642937
• Lead Sponsor: OX2 Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-24
• Study Start: 2020-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27
• Primary Completion: 2023-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
hP1A8	Treatment with 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.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD	12 months

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	12 months
Time to progression (TTP)	24 months
Overall survival (OS)	24 months
Progression free survival (PFS)	24 months

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States