Actively Recruiting
A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia
Led by City of Hope Medical Center · Updated on 2026-03-05
80
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing COVID-19 infections in patients with chronic lymphocytic leukemia (CLL). The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at boosting COVID-19 immunity in patients with poor immune responses. MVA strongly induces T cell expansion (infection fighting blood cells) even in the background of a suppressed immune system, which is the case in the targeted CLL patient population. Using the GEO-CM04S1 vaccine may be more effective at preventing COVID-19 infection in patients diagnosed with CLL.
CONDITIONS
Official Title
A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Histologically confirmed diagnosis of chronic lymphocytic leukemia (CLL) according to WHO classification
- Received at least two doses of Pfizer or Moderna COVID-19 vaccine, with last dose at least 3 months prior
- Fully recovered from acute toxic effects of prior anti-cancer therapy to Grade 1 or less (except alopecia)
- White blood cell count of 1,000/mm³ or higher within 14 days prior to Day 1
- Platelet count of 50,000/mm³ or higher within 14 days prior to Day 1
- Total bilirubin less than or equal to 1.5 times upper limit of normal unless Gilbert's disease, within 14 days prior to Day 1
- AST less than or equal to 2.5 times upper limit of normal within 14 days prior to Day 1
- ALT less than or equal to 2.5 times upper limit of normal within 14 days prior to Day 1
- Creatinine clearance less than 1.5 times upper limit of normal within 14 days prior to Day 1
- Negative pregnancy test for women of childbearing potential within 14 days prior to Day 1
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for at least 6 weeks after last vaccine injection for participants of childbearing potential
You will not qualify if you...
- Current known SARS-CoV-2 infection
- Use of Evusheld or other anti-SARS-CoV-2 prophylaxis within 2 weeks prior
- Hematopoietic cell transplantation or CAR T cell therapy within the previous year
- Use of systemic corticosteroids above 0.5 mg/kg/day prednisone equivalent within 7 days of enrollment
- Intensive cytotoxic or T-cell depleting therapies within 30 days prior to enrollment, except stable maintenance therapies
- Receipt of live vaccine within 30 days prior to study vaccine or inactivated vaccines within 2 weeks
- History of allergic reactions to similar compounds as study vaccine
- Active infection not controlled by treatment
- History of adverse events with prior smallpox vaccination
- History of pericarditis or myocarditis
- Receipt of MVA or poxvirus vaccine within the last 12 months
- Pregnant or breastfeeding females
- Any condition that investigator judges unsafe for participation
- Inability to comply with study procedures according to investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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