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Checkpoint Inhibitor
rHSC-DIPGVax + Checkpoint Inhibitors for Brain Tumor
Phase 1
Recruiting
Led By Ashley Plant-Fox, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG
Histone mutation must be confirmed by pathology report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on-going during 1 year of therapy plus up to 5 years off treatment
Awards & highlights
Study Summary
This trial is testing a new cancer treatment on patients with a specific type of brain tumor. The treatment involves using two different drugs, and researchers are testing to see if it is safe and effective.
Who is the study for?
This trial is for children and teens (12 months to 18 years old) with newly diagnosed brain tumors called DIPG or DMG, who've finished radiation therapy recently. They need a confirmed histone mutation and measurable disease. Kids should be able to perform daily activities at least halfway normally, even if in a wheelchair, and not have received any cancer treatment other than radiation.Check my eligibility
What is being tested?
The trial tests rHSC-DIPGVax combined with two immune checkpoint inhibitors, Balstilimab and Zalifrelimab. It's an early-phase study focusing on safety and how well patients tolerate the treatment. The vaccine targets specific tumor markers while the drugs aim to boost the immune system against the tumor.See study design
What are the potential side effects?
Possible side effects include reactions related to stimulating the immune system such as inflammation in various organs, fatigue, flu-like symptoms from the vaccine component, allergic reactions to infusion of drugs, as well as potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a new diagnosis of a specific brain tumor confirmed by biopsy.
Select...
My cancer has a confirmed histone mutation.
Select...
My brain tumor is mainly in the pons and affects most of it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on-going during 1 year of therapy plus up to 5 years off treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on-going during 1 year of therapy plus up to 5 years off treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax
Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMAB
Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax plus BALSTILIMAB and ZALIFRELIMAB
Secondary outcome measures
Overall survival at 1 year
Time to progression
To evaluate the efficacy of the combination of rHSC-DIPGVax, BALSTILIMAB, and ZALIFRELIMB in pediatric subjects with DIPG and DMG as measured by overall survival at 12 months and time-to-progression as measured from time of diagnostic imaging
+1 moreOther outcome measures
To characterize PK profile (AUC) of BALSTILIMAB as a mAb monotherapy with rHSC-DIPGVax and in mAb combination with ZALIFRELIMAB and rHSC-DIPGVax to assess potential impact on PK exposure and biologic activity in pediatrics
To characterize PK profile (Cmax) of BALSTILIMAB as a mAb monotherapy with rHSC-DIPGVax and in mAb combination with ZALIFRELIMAB and rHSC-DIPGVax to assess potential impact on PK exposure and biologic activity in pediatrics
To evaluate biologic correlates for immune response in order to assess neo-antigen specific T cell responses
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part C: Dose ExpansionExperimental Treatment3 Interventions
rHSC-DIPGVax (8 total doses) + BALSTILIMAB + ZALIFRELIMAB (at RP2D from Part B) (1 year of therapy or 9 cycles, whichever comes first)
Patients will enroll 6-10 weeks post standard of care (SOC) radiation therapy. Steroid dose must be at or below 0.5mg/kg/day for a minimum of 7 days. Up to 12 patients will be enrolled on Part C. All subjects in Part C will be monitored for DLT's for the duration of their participation in the study to monitor for excess toxicity.
Group II: Part B: Dose Escalation of ZALIFRELIMAB (Anti-CTLA4)Experimental Treatment3 Interventions
rHSC-DIPGVax (8 total doses) + BALSTILIMAB + ZALIFRELIMAB (1 year of therapy or 9 cycles, whichever comes first)
Patients will enroll 6-10 weeks post standard of care (SOC) radiation therapy. Steroid dose must be at or below 0.5mg/kg/day for a minimum of 7 days. The first 3 patients must be 5 years or older to 18. Subsequently, subjects ages 12 months to 18 years can be enrolled. Up to 12 patients will be enrolled on Part B. Once safety is established for rHSC-DIPGVax plus anti-PD1 (BALSTILIMAB) plus anti-CTLA4 (ZALIFRELIMAB), the study will proceed to Part C.
Group III: Part A: rHSC-DIPGVax in Combination with BALSTILIMAB (Anti-PD1)Experimental Treatment2 Interventions
rHSC-DIPGVax (8 total doses) + BALSTILIMAB (1 year of therapy or 27 cycles, whichever comes first)
Patients will enroll 6-10 weeks post standard of care (SOC) radiation completion. Steroid dose must be at or below 0.5mg/kg/day for a minimum of 7 days. The first 3 patients must be 5 years or older to 18. Subsequently, subjects ages 12 months to 18 years can be enrolled. Up to six patients will be enrolled on Part A. Once safety is established for rHSC-DIPGVax plus anti-PD1 (BALSTILIMAB), the study will proceed to Part B.
Group IV: "Lead In": rHSC-DIPGVax MonotherapyExperimental Treatment1 Intervention
rHSC-DIPGVax for 8 total doses
Find a Location
Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
258 Previous Clinical Trials
5,189,094 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
53 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,944 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
4 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Children's Hospital of Orange CountyOTHER
32 Previous Clinical Trials
4,898 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have reduced my corticosteroid dose to ≤0.5mg/kg/day for at least 7 days.I currently have a lung infection or breathing problem.I am between 1 and 18 years old.I have reduced my steroid use to less than or equal to 0.5mg/kg/day for at least 7 days.I am not taking temozolomide with my radiation therapy.I have a new diagnosis of a specific brain tumor confirmed by biopsy.My cancer has spread to other parts of my body.I currently have an active viral infection.My cancer has a confirmed histone mutation.My brain tumor is mainly in the pons and affects most of it.I have received cancer treatment other than radiation.I can perform daily activities with minimal assistance, regardless of my age.I will start radiation within 6 weeks of my diagnosis and won't take temozolomide with it.My cancer can be measured by tests or scans.My body surface area is at least 0.35 square meters.I am between 12 months and 18 years old.I can do most activities myself, even if I use a wheelchair.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Dose Escalation of ZALIFRELIMAB (Anti-CTLA4)
- Group 2: Part C: Dose Expansion
- Group 3: "Lead In": rHSC-DIPGVax Monotherapy
- Group 4: Part A: rHSC-DIPGVax in Combination with BALSTILIMAB (Anti-PD1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the trial include participants of advanced age?
"Participants eligible for inclusion in this study must be between 12 months and 18 years of age."
Answered by AI
Is this research the inaugural exploration of its kind?
"Agenus Inc.'s rHSC-DIPGVax has been the subject of 7 live trials across 100 cities and 9 countries since its initial trial in 2019. These studies have had a total enrollment of 195 test subjects, with 3 completed Phase 1 drug approval stages as of this moment."
Answered by AI
Has rHSC-DIPGVax been the focus of any prior investigations?
"Initially studied in 2019 at Columbia University Irving Medical Center, rHSC-DIPGVax has been the subject of 3 completed studies. Currently, 7 active research trials are being conducted with many based out of Boston, Massachusetts."
Answered by AI
Has the FDA sanctioned rHSC-DIPGVax for public use?
"While there is limited clinical evidence for both its efficacy and safety, rHSC-DIPGVax has been tentatively assigned a score of 1."
Answered by AI
Is this experiment presently accepting new participants?
"Affirmative. Information hosted on clinicaltrials.gov implies that this trial is actively enrolling individuals, and was originally published on January 10th 2022 with the most recent update being November 10th 2022. Currently, 36 patients are needed from 3 distinct sites."
Answered by AI
What are the criteria for entrance into this clinical trial?
"Successful applicants must have a diagnosis of Diffuse Intrinsic Pontine Glioma, and be between 12 months old to 18 years in age. The research team is looking for approximately 36 participants."
Answered by AI
What is the current size of the cohort participating in this experiment?
"In order for this trial to be a success, 36 volunteers who meet the necessary requirements need to enroll. People can join from Dana-Farber Boston Children's Cancer and Blood Disorders Center in Massachusetts or CHOC in California."
Answered by AI
What are the primary aims of this medical experiment?
"The primary purpose of this clinical trial, which will be evaluated over a 28-day duration for Part A, is to assess Safety and Tolerability: Dose limiting toxicities of rHSC-DIPGVax. Other secondary goals include gauging Overall survival at 1 year from the time of diagnostic imaging to death and recording Total number of DLT's for ZALIFRELIMAB at RP2D in combination with rHSC-DIPGVax and BALSTILIMAB using CTCAE version 5.0 guidelines and iRANO standards as well as Time to progression between diagnosis and disease development."
Answered by AI
Who else is applying?
What state do they live in?
South Dakota
How old are they?
< 18
What site did they apply to?
Dana-Farber Boston Children's Cancer and Blood Disorders Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- Dana-Farber Boston Children's Cancer and Blood Disorders Center: < 24 hours
Average response time
- < 1 Day
Typically responds via
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