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Virus Therapy
Vaccine Booster GEO-CM04S1 for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Alexey V Danilov
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of CLL according to World Health Organization (WHO) classification
Eastern Cooperative Oncology Group (ECOG) =< 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial compares a new vaccine to the standard one to see if it better prevents COVID-19 in people with CLL (a type of cancer). The new vaccine activates infection-fighting blood cells in people with weakened immunity.
Who is the study for?
Adults diagnosed with chronic lymphocytic leukemia (CLL) who have had at least two Pfizer or Moderna COVID-19 vaccines over three months ago can join. They should be in good health otherwise, not pregnant, and willing to use birth control. People with recent intensive cancer treatments, certain allergies, a history of heart inflammation, or those on high-dose steroids cannot participate.Check my eligibility
What is being tested?
The trial is testing the GEO-CM04S1 vaccine booster against standard COVID-19 vaccines for CLL patients. The new vaccine uses a modified virus that might better stimulate immune cells even when the immune system is weakened by CLL.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical vaccine reactions like soreness at the injection site, fatigue, fever, and allergic responses due to components similar to other vaccines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of CLL is confirmed by lab tests.
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I am fully active and can carry on all pre-disease activities without restriction.
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I am 18 years old or older.
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I have recovered from side effects of cancer treatment, except for hair loss.
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My liver enzyme (ALT) levels are within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Confirmed COVID-19 infection by PCR viral load
Incidence of AEs unacceptable toxicity (UT)
Incidence of adverse events (AEs) moderate toxicity (MOD)
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (GEO-CM04S1)Experimental Treatment2 Interventions
Patients receive GEO-CM04S1 vaccine IM on days 0 and 84 on study. Patients undergo blood sample collections throughout the study and are monitored for 1 year.
Group II: Arm II (mRNA Covid-19 Vaccine)Active Control2 Interventions
Patients receive mRNA vaccine injection IM on days 0 and 84 on study. Patients undergo blood sample collections throughout the study and are monitored for 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,580 Total Patients Enrolled
1 Trials studying Coronavirus Disease
189 Patients Enrolled for Coronavirus Disease
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,241 Total Patients Enrolled
1 Trials studying Coronavirus Disease
189 Patients Enrolled for Coronavirus Disease
Alexey V DanilovPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
54 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pericarditis or myocarditis in the past.My bilirubin levels are normal or slightly above, unless I have Gilbert's disease.Your platelet count needs to be at least 50,000 per cubic millimeter within 14 days before starting the treatment.I have not received a poxvirus vaccine in the last year.I have an infection that isn't getting better with treatment.Your aspartate aminotransferase (AST) level should be no more than 2.5 times the upper limit of normal. This test should be done within 14 days before starting the treatment.I haven't had strong cancer treatments or T-cell therapies in the last 30 days.My diagnosis of CLL is confirmed by lab tests.Women who could become pregnant must have a negative pregnancy test within 14 days before starting the treatment.I haven't had COVID-19 prevention treatment like Evusheld in the last 2 weeks.I received at least 2 doses of Pfizer or Moderna COVID-19 vaccine, with the last dose over 3 months ago.I am not pregnant or breastfeeding.I haven't had a live vaccine within the last 30 days or an inactivated vaccine within the last 2 weeks.I am fully active and can carry on all pre-disease activities without restriction.I currently have COVID-19.I take more than 0.5mg/kg/day of steroids for a chronic condition.I am 18 years old or older.I am capable of having children and have not been surgically sterilized.I have recovered from side effects of cancer treatment, except for hair loss.Your white blood cell count is at least 1,000 per cubic millimeter.My liver enzyme (ALT) levels are within the normal range.I have not had a bone marrow transplant or CAR T cell therapy in the last year.My kidney function test shows creatinine clearance is normal.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (GEO-CM04S1)
- Group 2: Arm II (mRNA Covid-19 Vaccine)
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.
Has Arm I (GEO-CM04S1) received regulatory authorization?
"Arm I (GEO-CM04S1) was rated a 2 on the safety scale, as it is currently at Phase 2 with some evidence of safety but no data to back up its efficacy."
Answered by AI
Are there still openings for volunteers in this experiment?
"The information posted on clinicaltrials.gov indicates that this specific medical trial is not currently in search of participants. The study, which was initially published on April 1st 2023 and most recently revised on January 3rd 2023, has yet to recruit any patients; however, there are 2290 trials actively searching for volunteers at the moment."
Answered by AI
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