Recruiting
Phase 1

OSU-2131 & QS-21

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06741072

Conditions

Chronic Kidney Disease, Stage 4

Chronic Kidney Disease, Stage 5

EBV-Related Lymphoproliferative Disorder

EBV-Related Malignant Neoplasm

Post-Transplant Lymphoproliferative Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Dulbecco''s Phosphate-Buffered Saline

Peptide Vaccine

QS21

Study Details

Brief summary:

This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.

Conditions

Chronic Kidney Disease, Stage 4

Chronic Kidney Disease, Stage 5

EBV-Related Lymphoproliferative Disorder

EBV-Related Malignant Neoplasm

Post-Transplant Lymphoproliferative Disorder

Study ID

NCT06741072

Start date

Jun 28, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\*08:01
  • Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive
  • Subjects must be seronegative for HIV
  • Subjects must be seronegative for hepatitis B and C
  • Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits
  • Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal
  • Platelets above the lower limit of normal (LLN)
  • Basophils, lymphocytes, and monocytes must be within 1.2 x upper limit of normal (ULN) or 0.8 x LLN and considered not clinically significant by the investigator
  • Total creatine kinase (CK) laboratory values < 1.25 x the upper limit of normal (according to the normal reference ranges of the Ohio State University \[OSU\] laboratory) at baseline (screening \& pre-study visit) and considered not clinically significant by the investigator
  • Subjects must not be taking antiviral therapy
  • Must be ≥ 18 years of age and ≤ 65 years of age and willing to either use an effective method of contraception or abstain from sexual activity for at least 3 months following the last dose of vaccination
  • Female of childbearing potential must have a negative serum pregnancy test prior to the first study drug/placebo (PBS) administration
  • Agree not to receive any other investigational drug while enrolled in this study
  • Provide written informed consent according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local regulations
  • Following successful completion of safety evaluation for the phase 1 dose escalation phase of this trial in healthy volunteers and review of this data by the Sponsor and Food and Drug Administration (FDA), we plan to enroll a second cohort of patients awaiting solid organ transplantation (SOT). We will recruit patients with end stage renal disease (ESRD) who are awaiting kidney transplantation. ESRD is defined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease (Acosta-Ochoa et al, J Clin Med, 8(9):1323, 2019). KDIGO defines ESRD as: stage 4: severe reduction in glomerular filtration rate (GFR) (15 to 29 mL/min); stage 5: renal failure (GFR less than 15 mL/min). Patients will qualify for ESRD / kidney transplantation per need for maintenance dialysis due to one or more of the criteria related to renal insufficiency: volume overload, metabolic acidosis, electrolyte disturbance, drug toxicity, etc. Patients will be regularly undergoing hemodialysis or peritoneal dialysis for metabolic support. Patients will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

Exclusion Criteria:

  • Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion
  • History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)
  • History of immune suppression or autoimmune disorder
  • Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable
  • Pregnant or breastfeeding subjects
  • For patient enrollment on the second cohort, "patients awaiting SOT", we will consider patients awaiting kidney transplantation who are receiving maintenance renal replacement therapy (dialysis). Most patients on routine renal replacement therapy (dialysis) will present with stable chemistry, acid base balance, volume status and clear mental status. For patients who are non-compliant with routine dialysis, laboratory abnormalities and acid base, volume status can become abnormal. Specific dose limiting toxicity (DLT) criteria that may relate to patients with ESRD include laboratory parameters that may altered due to missed dialysis session(s). Most laboratory abnormalities in such patients can be corrected by restarting dialysis or blood transfusions. Outside these specific variables, we do not expect to see specific DLT criteria for patients with ESRD on this study. Metabolic derangement such as acid base imbalance, hyperkalemia and volume overload as a result of missing dialysis session. Study stopping rule for subjects awaiting organ transplant: Occurrence of this event in two or more subjects should result in study pause. Patients who are unable to adhere to routine dialysis will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group I (OSU-2131, QS-21)

Healthy volunteers and patients receive OSU-2131 SC with QS-21 SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity or patient proceeds to transplant. Healthy volunteers and patients additionally undergo blood sample collection throughout the study.

placebo comparator: Group II (placebo)

Healthy volunteers receive PBS SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity. Healthy volunteers additionally undergo blood sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Dulbecco''s Phosphate-Buffered Saline

Given SC

Peptide Vaccine

Given OSU-2131 SC

QS21

Given SC

Primary outcome measure

  • Incidence of treatment-emergent adverse events [ Time Frame: From the first administration of treatment until the week 28 visit ]
  • Changes in laboratory parameters and vital signs [ Time Frame: At baseline and up to week 56 ]
  • Pre- and post-injection vital signs [ Time Frame: Up to week 4 ]
  • Injection site reactions [ Time Frame: At 10 and/or 60 minutes post injection on weeks 0, 2 and 4 ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Timothy J. Voorhees, MD

614-293-6947Timothy.Voorhees@osumc.edu

Principal Investigator:

Timothy J. Voorhees

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-07-02.