New vaccine aims to shield leukemia patients from COVID-19
NCT ID NCT05672355
First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This phase 2 trial tests a new COVID-19 booster vaccine (GEO-CM04S1) in 80 people with chronic lymphocytic leukemia (CLL). The goal is to see if this vaccine triggers a stronger immune response than standard mRNA boosters. Participants will receive either the new vaccine or a standard mRNA booster, and their T cell responses will be measured.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GEO-CM04S1 vaccine (modified vaccinia virus-based COVID-19 vaccine)
- What this could lead to
- If successful, this could provide a more effective COVID-19 booster for people with weakened immune systems, like CLL patients.
- What could go wrong
- This is a small, early-phase trial that is currently suspended. The vaccine may not produce a strong immune response or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
47 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age: \>= 18 years * Eastern Cooperative Oncology Group (ECOG) =\< 1 * Histologically confirmed diagnosis of CLL according to World Health Organization (WHO) classification * Prior COVID-19 Vaccination (2 or more Pfizer or Moderna) with last injection \>= 3 months prior * Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior anti-cancer therapy * White Blood Cells (WBC) \>= 1,000/mm\^3 (To be performed within 14 days prior to Day 1 of protocol therapy) * Platelets \>= 50,000/mm\^3 (To be performed within 14 days prior to Day 1 of protocol therapy) * Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (To be performed within 14 days prior to Day 1 of protocol therapy) * Aspartate aminotransferase (AST) =\< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy) * Alanine transaminase (ALT) =\< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy) * Creatinine clearance \<1.5 ULN (To be performed within 14 days prior to Day 1 of protocol therapy) * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (To be performed within 14 days prior to Day 1 of protocol therapy) * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 weeks after the last vaccine injection * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Known current SARS CoV-2 infection * Prior Evusheld or other anti-SARS CoV-2 prophylaxis \< 2 weeks prior * Prior hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T cell therapy within the previous year * Systemic corticosteroids required for chronic conditions at doses \> 0.5mg/kg/day prednisone equivalent within 7 days of enrollment * Intensive cytotoxic therapies, T-cell depleting therapies, within 30 days of enrollment; however, patients with stable disease on maintenance therapies are allowed (See ConMeds for lists of acceptable and contraindicated therapies) * Participants who have had a live vaccine =\< 30 days prior to administration of any dose of study vaccine or subjects who are =\< 2 weeks within administration of inactivated vaccines (e.g., influenza vaccine). Flu shots are allowed \> 2 weeks before a study vaccine injection and \> 2 weeks post study vaccine injection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (e.g., egg allergies) * Active infection not controlled on appropriate therapy * History of adverse event with a prior smallpox vaccination * History of pericarditis or myocarditis * Any MVA vaccine or poxvirus vaccine in the last 12 months * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?