Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305910
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMGDIPG in Children and Young Adults
Sponsor:
OX2 Therapeutics
Organization:
OX2 Therapeutics
Study Overview
Official Title:
Phase I Trial CD200 Activation Receptor Ligand CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy With Adjuvant Reirradiation for Recurrent High-Grade Glioma and Newly Diagnosed Diffuse Midline GliomaDiffuse Intrinsic Pontine Glioma in Children and Young Adults
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand CD200AR-L in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults
The primary objective of this study is to determine the maximum tolerated dose MTD of CD200AR-L when given with a fixed dose of GBM6-AD vaccine imiquimod and a single dose of radiation for patients with recurrent High Grade Glioma HGG or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline GliomaDiffuse Intrinsic Pontine Glioma DIPGDMG
The primary objective of this study is to determine the maximum tolerated dose MTD of CD200AR-L when given with a fixed dose of GBM6-AD vaccine imiquimod and a single dose of radiation for patients with recurrent High Grade Glioma HGG or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline GliomaDiffuse Intrinsic Pontine Glioma DIPGDMG
Detailed Description:
A previous pediatric trial using GBM6-AD vaccine was found to be safe and an appropriate pediatric dose of GBM6-AD was determined but the efficacy of the vaccine was diminished due to secretion of CD200 by the patients HGG or DMGDIPG cells CD200 is known to binds to CD200 inhibitory receptor CD200R1 on immune cells and suppress the immune cell response Laboratory studies have shown that administering agents that bind to the CD200 activation receptor CD200-AR on immune cells results in activation of immune cells and overcomes any inhibitory signals caused by CD200
CD200AR-L is a newly developed agent that binds to CD200-AR This trial will assess the combination of CD200AR-L with GBM6-AD vaccine imiquimod cream and a single dose of radiation given on day 15 for the treatment of recurrent HGG and newly diagnosed DMGDIPG
This study has the following primary goals
1 To determine the maximum tolerated dose and side-effects of the experimental medicine CD200AR-L when given with a fixed dose of GBM6-AD vaccine in combination with imiquimod cream and a single dose of radiation on Day 15 for patients with recurrent HGG or newly diagnosed DMGDIPG in children
2 To use the information from this study to design a larger study of the GBM6-AD vaccine and CD200AR-L treatment to assess the effectiveness of this combination vaccine in pediatric HGG and newly diagnosed DMGDIPG
Study treatment consists of CD200AR-L GBM6-AD vaccine and imiquimod along with a single dose of radiation on day 15 Study treatment will begin approximately 14 days after the completion of standard of care radiation therapy for patients with newly diagnosed DMGDIPG and at the time of recurrence for patients with HGG The study will enroll patients between the ages of 2 - 25 years but it will initially enroll and treat 3 patients age 12 years in the first dosing cohort in order to acquire safety data before enrolling patients 2-11 years of age Up to 3 dose levels of CD200AR-L will be tested with dose reduction in the event of toxicity
Each vaccine treatment is given as an outpatient visit on two consecutive days Imiquimod cream is applied to the supraclavicular site followed by 2 supraclavicular injections of CD200AR-L each day for 2 consecutive days On the second day following application of Imiquimod cream and CD200AR-L injection 2 supraclavicular injections of GBM6-AD vaccine will be given All CD200AR-L and GBM6-AD vaccine administrations must be done at Childrens Minnesota Two-day injection series will be administered every week for the first 3 weeks then every 4 weeks starting at week 7 for the next 8 weeks then every 8 weeks starting at week 19 for 2 years On day 15 a single dose of 300 cGy radiation will be given to help sensitize the tumor to immune attack The patient will undergo a series of MRIs to follow the status of their tumor blood work for immune characterization and pediatric functional performance assessments Treatment will continue for 2 years unless disease progression is noted on MRI unacceptable toxicity develops a greater than 8-week treatment delay occurs during the maintenance phase or the patient withdraws from the study The patient will have an option of continuing therapy beyond 2 years if they are tolerating the treatment and if their tumor is controlled by the treatment
CD200AR-L is a newly developed agent that binds to CD200-AR This trial will assess the combination of CD200AR-L with GBM6-AD vaccine imiquimod cream and a single dose of radiation given on day 15 for the treatment of recurrent HGG and newly diagnosed DMGDIPG
This study has the following primary goals
1 To determine the maximum tolerated dose and side-effects of the experimental medicine CD200AR-L when given with a fixed dose of GBM6-AD vaccine in combination with imiquimod cream and a single dose of radiation on Day 15 for patients with recurrent HGG or newly diagnosed DMGDIPG in children
2 To use the information from this study to design a larger study of the GBM6-AD vaccine and CD200AR-L treatment to assess the effectiveness of this combination vaccine in pediatric HGG and newly diagnosed DMGDIPG
Study treatment consists of CD200AR-L GBM6-AD vaccine and imiquimod along with a single dose of radiation on day 15 Study treatment will begin approximately 14 days after the completion of standard of care radiation therapy for patients with newly diagnosed DMGDIPG and at the time of recurrence for patients with HGG The study will enroll patients between the ages of 2 - 25 years but it will initially enroll and treat 3 patients age 12 years in the first dosing cohort in order to acquire safety data before enrolling patients 2-11 years of age Up to 3 dose levels of CD200AR-L will be tested with dose reduction in the event of toxicity
Each vaccine treatment is given as an outpatient visit on two consecutive days Imiquimod cream is applied to the supraclavicular site followed by 2 supraclavicular injections of CD200AR-L each day for 2 consecutive days On the second day following application of Imiquimod cream and CD200AR-L injection 2 supraclavicular injections of GBM6-AD vaccine will be given All CD200AR-L and GBM6-AD vaccine administrations must be done at Childrens Minnesota Two-day injection series will be administered every week for the first 3 weeks then every 4 weeks starting at week 7 for the next 8 weeks then every 8 weeks starting at week 19 for 2 years On day 15 a single dose of 300 cGy radiation will be given to help sensitize the tumor to immune attack The patient will undergo a series of MRIs to follow the status of their tumor blood work for immune characterization and pediatric functional performance assessments Treatment will continue for 2 years unless disease progression is noted on MRI unacceptable toxicity develops a greater than 8-week treatment delay occurs during the maintenance phase or the patient withdraws from the study The patient will have an option of continuing therapy beyond 2 years if they are tolerating the treatment and if their tumor is controlled by the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None