OncoMatch/Clinical Trials/NCT05672355
A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia
Is NCT05672355 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including mRNA COVID-19 Vaccine and Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 for chronic lymphocytic leukemia.
Treatment: mRNA COVID-19 Vaccine · Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: COVID-19 vaccine (Pfizer, Moderna)
Prior COVID-19 Vaccination (2 or more Pfizer or Moderna) with last injection >= 3 months prior
Cannot have received: Evusheld or other anti-SARS CoV-2 prophylaxis
Prior Evusheld or other anti-SARS CoV-2 prophylaxis < 2 weeks prior
Cannot have received: hematopoietic cell transplantation
Prior hematopoietic cell transplantation (HCT) ... within the previous year
Cannot have received: CAR-T cell therapy
chimeric antigen receptor (CAR) T cell therapy within the previous year
Cannot have received: intensive cytotoxic therapies
Exception: patients with stable disease on maintenance therapies are allowed
Intensive cytotoxic therapies, T-cell depleting therapies, within 30 days of enrollment; however, patients with stable disease on maintenance therapies are allowed
Cannot have received: T-cell depleting therapies
Exception: patients with stable disease on maintenance therapies are allowed
Intensive cytotoxic therapies, T-cell depleting therapies, within 30 days of enrollment; however, patients with stable disease on maintenance therapies are allowed
Cannot have received: live vaccine
Participants who have had a live vaccine <= 30 days prior to administration of any dose of study vaccine
Cannot have received: inactivated vaccine (influenza vaccine)
Exception: Flu shots are allowed > 2 weeks before a study vaccine injection and > 2 weeks post study vaccine injection
subjects who are <= 2 weeks within administration of inactivated vaccines (e.g., influenza vaccine)
Cannot have received: MVA vaccine
Any MVA vaccine or poxvirus vaccine in the last 12 months
Cannot have received: poxvirus vaccine
Any MVA vaccine or poxvirus vaccine in the last 12 months
Lab requirements
Blood counts
White Blood Cells (WBC) >= 1,000/mm^3; Platelets >= 50,000/mm^3
Kidney function
Creatinine clearance <1.5 ULN
Liver function
Total bilirubin <= 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease); AST <= 2.5 x ULN; ALT <= 2.5 x ULN
White Blood Cells (WBC) >= 1,000/mm^3; Platelets >= 50,000/mm^3; Total bilirubin <= 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease); AST <= 2.5 x ULN; ALT <= 2.5 x ULN; Creatinine clearance <1.5 ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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