Study of CD200 Activation Receptor Ligand (CD200AR-L) and... | NCT04642937

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

NCT04642937

Sponsor

OX2 Therapeutics

Status

Unknown status

Last Update Posted

Jan 27, 2023Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Glioblastoma

Interventions

Treatment with hP1A8

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Nov 2023Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Nov 19, 2020

First Submission Date that Met QC Criteria

Nov 19, 2020

First Posted Date

Nov 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2023

Last Update Posted Date

Jan 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Treatment with hP1A8

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment with hP1A8	Drug	Treatment with hP1A8	hP1A8

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided