Vaccine Therapy for Blood Cancers

No longer recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Live vaccines, Antivirals, Alemtuzumab, others

Disqualifiers: Autoimmune conditions, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine therapy to determine if it can prevent severe infections caused by cytomegalovirus (CMV) in individuals with certain blood cancers undergoing stem cell transplants. The vaccine, CMVpp65-A*0201 peptide vaccine, uses a peptide to enhance the immune system's response against CMV. Participants must have a history of blood cancers such as lymphoma or leukemia and be scheduled for a donor stem cell transplant. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but certain medications are not allowed from the time of transplant to day 70 after. These include live vaccines, some antiviral drugs, and medications that might interfere with the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CMVpp65-A*0201 peptide vaccine is designed to help the immune system fight cytomegalovirus (CMV) after a stem cell transplant. This vaccine boosts the body's defenses, enabling specific immune cells to target CMV.

Previous studies have examined the vaccine's safety in people and indicate that it is generally well-tolerated. Some participants might experience mild side effects, such as redness or swelling at the injection site. These studies have reported no serious side effects directly linked to the vaccine.

The CMVpp65-A*0201 peptide vaccine is now being tested in a phase 2 trial, indicating it has already passed initial safety checks in earlier trials. This suggests the vaccine has shown some level of safety in humans so far. However, more research is needed to fully understand its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for blood cancers, which often involve chemotherapy or stem cell transplants, the CMVpp65-A*0201 peptide vaccine offers a novel approach by harnessing the power of the immune system. This treatment is designed to stimulate the body's own defenses specifically against cancer cells, using a targeted peptide to boost immune response post-transplant. Researchers are excited about this vaccine because it could potentially reduce the risk of infection and relapse by enhancing immunity, a unique mechanism compared to existing therapies. Moreover, the vaccine is administered subcutaneously, making it a non-invasive option with the potential for fewer side effects.

What evidence suggests that the CMVpp65-A*0201 peptide vaccine might be an effective treatment for reducing cytomegalovirus events in blood cancer patients?

Research has shown that the CMVpp65-A*0201 peptide vaccine, which participants in this trial may receive, might help the body build a strong defense against cytomegalovirus (CMV). In earlier studies, patients who received a similar CMV vaccine experienced fewer instances of the virus reactivating and required less antiviral medication. The vaccine trains the immune system to better recognize and fight the virus, potentially reducing serious CMV infections in patients receiving donor stem cell transplants. Overall, the initial results are promising, suggesting the vaccine might effectively manage CMV in these patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Ryotaro Nakamura, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with blood cancers like lymphoma, leukemia, and myelodysplastic syndrome who are undergoing stem cell transplants. They must understand the study, agree to follow-up procedures for a year post-transplant, be HLA A*0201 positive, CMV seropositive, not pregnant or breastfeeding, willing to use contraception and have no recent experimental anti-CMV treatments.

Inclusion Criteria

My leukemia is in an early or slightly advanced stage.

Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT

My leukemia is in the first or second remission without worsening, despite some lymph node swelling.

Exclusion Criteria

You have not previously participated in a study involving an experimental CMV vaccine.

Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etc

I will be taking specific medications from my transplant until day 70 after.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CMVpp65-A*0201 peptide vaccine or placebo subcutaneously on days 28 and 56 after HCT

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CMV reactivation and immune response

Up to 365 days after HCT

What Are the Treatments Tested in This Trial?

Interventions

• CMVpp65-A*0201 peptide vaccine

Trial Overview The trial tests if a vaccine made from a peptide can reduce severe cytomegalovirus infections in patients after donor stem cell transplant. It's randomized: some get the actual vaccine while others receive a placebo. The goal is to see how well the immune system responds.

How Is the Trial Designed?

Group I: Arm I (CMVpp65-A*0201 peptide vaccine) Experimental Treatment 2 Interventions

Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.

Group II: Arm II (placebo) Placebo Group 2 Interventions

Patients receive placebo SC on days 28 and 56 after HCT.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02396134?cond=myelofibrosis

Study Details | NCT02396134 | Vaccine Therapy in ... Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11860334/

Therapeutic Vaccines for Hematological Cancers: A Scoping ... This review systematically identifies and analyzes recent studies focused on the development of therapeutic immunotherapy vaccines.

3. haematologica.org haematologica.org/article/view/haematol.2023.284544

A phase II randomized, placebo-controlled, multicenter trial ... A phase I trial of PepVax, an investigational CMV vaccine showed safety, immunogenicity, and reduced CMV reactivation and usage of antivirals, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2200809/

Leukemia-associated antigen-specific T-cell responses ... In this phase 1 safety study, 8 HLA-A*0201–positive patients with myeloid malignancies received a single dose of a combination of PR1 and WT1 vaccines. The ...

5. ehoonline.biomedcentral.com ehoonline.biomedcentral.com/articles/10.1186/s40164-025-00662-3

Exploring the efficacy of CAR-T and cancer vaccines This review describes the various immunotherapeutic approaches targeting leukemia, emphasizing the roles and interplay of cancer vaccines and CAR-T cell ...

6. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/cmvpp65-a0201-peptide-vaccine

Definition of CMVpp65-A*0201 peptide vaccine Upon subcutaneous administration, CMVpp65-A*0201 peptide vaccine may stimulate a cytotoxic T lymphocyte (CTL) response against CMV-positive cells, resulting in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4926626/

Cytomegalovirus chimeric epitope vaccine supplemented with ... The objective for the CMVPepVax vaccine is to stimulate a CD8 T-cell response directed towards pp65495–503, a dominant T-cell epitope of the pp65 tegument ...

8. ashpublications.org ashpublications.org/blood/article/90/5/1751/139355/Development-of-a-Candidate-HLA-A-0201-Restricted

Development of a Candidate HLA A*0201 Restricted Peptide ... These studies suggest that the HLA A*0201 restricted peptide is a candidate CTL epitope vaccine to prevent or minimize HCMV infection after BMT. MATERIALS AND ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0006497120485623

Leukemia-associated antigen-specific T-cell responses ... We describe the safety and immunogenicity of a combined vaccine of 2 leukemia-associated antigenic peptides, PR1 and WT1.