# City of Hope Core Clinical Center for the Blood and Marrow Transplant Clinical Trials Network

> **NIH NIH UG1** · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · 2023 · $207,600

## Abstract

PROJECT SUMMARY
This grant application seeks to renew our status as a Core Clinical Center and member of the Steering
Committee of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The City of Hope
Hematopoietic Cell Transplantation Program has focused its efforts over the last 40 years on the development
of laboratory-based translational research and Phase I, II and III clinical trials leading to improvements in
hematopoietic cell transplantation (HCT) for the treatment of malignant and non-malignant hematologic
disorders. During our 15 years as a member of the BMT CTN, we have participated in the development of clinical
trials focused on important questions confronting HCT patients, several of which were derived from early phase
studies conducted in our program. Many of our faculty members significantly contributed to the successful
conduct of the BMT CTN trials and will continue to collectively work toward the common goal of improving
outcomes of HCT. As the largest and oldest HCT center in California we offer unique and highly qualified
capabilities for accruing diverse patients and supporting multi-center HCT trials, including cellular therapeutics.
City of Hope has a longstanding research focus on cytomegalovirus (CMV), the most significant infectious
complication post-HCT, addressing the unmet need to improve the current shortfalls of anti-viral drug-based
approaches. Our laboratory collaborators have developed and manufactured a CMV vaccine (CMVPepVax)
utilizing the HLA A*0201 pp65495-503 CD8+ T cell epitope fused to a universal TH epitope (a natural Tetanus
sequence) that is co-injected with the CpG adjuvant PF-03512676. This vaccine has demonstrated safety and
immunogenicity in a phase Ib trial of healthy volunteers and in HCT recipients, with promising efficacy signals in
reducing CMV reactivation. The placebo-controlled randomized phase II trial of CMVPepVax is currently
underway and accruing well. As part of this application we propose that the BMT CTN, in collaboration with City
of Hope and the license holder Helocyte, conducts a prospective Phase III randomized, double-blind, multi-
center trial of CMVPepVax versus placebo in patients receiving HCT from matched related or unrelated donors.
Our study hypothesis is that use of CMVPepVax on days 28 and 56 post-HCT will improve the 12-month CMV-
free survival in the vaccine arm compared to the placebo arm.

## Key facts

- **NIH application ID:** 10657661
- **Project number:** 5UG1HL069278-23
- **Recipient organization:** BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
- **Principal Investigator:** RYOTARO NAKAMURA
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $207,600
- **Award type:** 5
- **Project period:** 2001-09-30 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10657661

## Citation

> US National Institutes of Health, RePORTER application 10657661, City of Hope Core Clinical Center for the Blood and Marrow Transplant Clinical Trials Network (5UG1HL069278-23). Retrieved via AI Analytics 2026-06-10 from https://api.ai-analytics.org/grant/nih/10657661. Licensed CC0.

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