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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
Must not have
Required steroid increase within 2 weeks prior to date of C5252 administration
Bleeding diathesis, or requirement for anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery or biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from c5252 injection
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I needed more steroids in the last 2 weeks before starting C5252.
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I cannot stop my blood thinners for surgery or biopsy.
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My brain tumor shows up on contrast imaging but doesn't fit the study requirements.
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I don't have any serious illnesses or mental health issues that would stop me from following the study's requirements.
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I need to keep taking medication for herpes virus.
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I haven't taken immunosuppressive drugs in the last 28 days.
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I am currently infected with COVID-19.
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I have a history of brain infections or multiple sclerosis.
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I have an active cold sore.
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I have had an organ transplant.
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I have no other cancers except possibly skin cancer or cervical cancer that hasn't spread.
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I am allergic to certain virus-based therapies or immune system drugs.
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I have Li-Fraumeni Syndrome or a genetic issue related to the retinoblastoma gene.
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I do not have severe heart issues like recent heart attacks, unstable angina, or serious arrhythmias.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from c5252 injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from c5252 injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterize Dose Limiting Toxicities
Evaluate the safety and tolerability of C5252
Identify the maximum tolerated dose (MTD) and/or the RD of C5252
Secondary study objectives
Evaluate the PK of C5252
Evaluate the viral shedding of C5252
Overall Survival (OS)
+2 more
Other study objectives
Evaluate blood cytokines
Evaluate lymphocyte profiling

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

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

C5252 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05095441 — Phase 1
Glioblastoma Research Study Groups: Part 1: Dose Escalation, Part 2: Dose Expansion
Glioblastoma Clinical Trial 2023: C5252 Highlights & Side Effects. Trial Name: NCT05095441 — Phase 1
C5252 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05095441 — Phase 1
~19 spots leftby Dec 2025
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