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Monoclonal Antibodies
C5252 for Brain Cancer
Phase 1
Waitlist Available
Led By Randy Jensen, MD
Research Sponsored by ImmVira Pharma Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Residual lesion must be ≥ 1.0 cm and < 5.5 cm contrast-enhancing in diameter as determined by MRI
Evidence of progression by RANO criteria based on MRI scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from c5252 injection
Awards & highlights
Study Summary
This trial is testing a new drug to treat brain cancer. The goal is to see if it is safe and tolerated by patients.
Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma who've had 1-2 prior treatments. They must have a tumor size within specific limits, be in good physical condition (KPS ≥ 70), and expect to live more than 12 weeks. Participants need normal organ function and agree to use birth control. Excluded are those with certain medical conditions, CNS infections, increased steroids recently, immunosuppressive drugs within the last month, or active infections like hepatitis or COVID-19.Check my eligibility
What is being tested?
The study tests C5252 given as a single injection directly into the tumor of patients with glioblastoma to assess its safety and tolerability. It's an early-stage trial (Phase 1) where everyone gets the same experimental treatment without any comparison group.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions related to immune therapies such as inflammation at the injection site, flu-like symptoms, fatigue, allergic reactions or worsening of neurological symptoms due to brain swelling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer lesion is between 1.0 cm and 5.5 cm in size, confirmed by MRI.
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My MRI shows my brain tumor is growing.
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I am able to care for myself but may not be able to do active work.
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My brain tumor has returned and is confirmed as glioblastoma.
Select...
I am 18 years old or older.
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I understand and can follow the study's requirements.
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My organs and bone marrow are functioning normally.
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My condition worsened after 1 or 2 treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from c5252 injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from c5252 injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize Dose Limiting Toxicities
Evaluate the safety and tolerability of C5252
Identify the maximum tolerated dose (MTD) and/or the RD of C5252
Secondary outcome measures
Evaluate the PK of C5252
Evaluate the viral shedding of C5252
Overall Survival (OS)
+2 moreOther outcome measures
Evaluate blood cytokines
Evaluate lymphocyte profiling
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Recommended dose of C5252 as determined in Part 1 Dose Escalation in participants with glioblastoma
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention
C5252 single agent dose escalation in participants with glioblastoma
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Who is running the clinical trial?
ImmVira Pharma Co. LtdLead Sponsor
5 Previous Clinical Trials
481 Total Patients Enrolled
Randy Jensen, MDPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer lesion is between 1.0 cm and 5.5 cm in size, confirmed by MRI.My MRI shows my brain tumor is growing.I am able to care for myself but may not be able to do active work.I needed more steroids in the last 2 weeks before starting C5252.I cannot stop my blood thinners for surgery or biopsy.My brain tumor shows up on contrast imaging but doesn't fit the study requirements.I don't have any serious illnesses or mental health issues that would stop me from following the study's requirements.My brain tumor has returned and is confirmed as glioblastoma.I need to keep taking medication for herpes virus.I haven't taken immunosuppressive drugs in the last 28 days.I am currently infected with COVID-19.I am 18 years old or older.I understand and can follow the study's requirements.I have a history of brain infections or multiple sclerosis.I have an active cold sore.My side effects from previous treatments are mild or gone.My organs and bone marrow are functioning normally.My condition worsened after 1 or 2 treatments.I have had an organ transplant.I have no other cancers except possibly skin cancer or cervical cancer that hasn't spread.I am allergic to certain virus-based therapies or immune system drugs.I have Li-Fraumeni Syndrome or a genetic issue related to the retinoblastoma gene.I do not have severe heart issues like recent heart attacks, unstable angina, or serious arrhythmias.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Dose Expansion
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.
What are the primary aims of this medical experiment?
"ImmVira Pharma Co. Ltd, the sponsor of this clinical trial has reported that it aims to identify a Maximum Tolerated Dose (MTD) and/or Recommended Dosage (RD) over a period of 28 days following C5252 administration. Secondary objectives include evaluating viral shedding with qPCR tests in saliva, nasopharyngeal mucus, and urine; measuring anti-PD-1 antibody concentration in blood via Anti-PD-1 ELISA assay; measuring IL-12p70 levels in serum through an IL-12p70 ELISA test; assessing overall response rate based on Investigator Assessment for Neuro"
Answered by AI
What risks do patients face when taking C5252?
"With limited evidence of both efficacy and safety, C5252 was rated with a score of 1."
Answered by AI
Is it possible to still join this medical experiment?
"The posted information on clinicaltrials.gov indicates that this particular medical trial is not currently recruiting patients, having been initially listed in March 15th 2023 and last updated October 9th 2022. However, there are 887 other research studies actively enrolling at the present time."
Answered by AI
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