# BMT CTN Core - University of Minnesota

> **NIH NIH UG1** · UNIVERSITY OF MINNESOTA · 2024 · $232,500

## Abstract

PROJECT SUMMARY
Relapse prevention post-allogeneic hematopoietic cell transplantation (alloHCT) remains a paramount
challenge. This project aims to test a novel graft-versus-host disease (GVHD) prophylaxis regimen that could
also prevent malignant relapse. Our novel regimen accomplishes this goal by eliminating mycophenolate
mofetil (MMF) from a post-transplant cyclophosphamide (PTCy) and sirolimus (SIR)-based regimen, and
instead adding a novel, oral Aurora kinase A inhibitor that not only constrains GVHD through CD28 signal
transduction blockade but also provide direct anti-tumor effects. Elimination of both MMF and tacrolimus (TAC)
from our proposed regimen enhances graft-versus-leukemia (GVL) effects, further contributing to relapse
mitigation. We propose to compare our GVHD prophylaxis regimen of PTCy/SIR/VIC-1911 to the widely used
PTCy/SIR/mycophenolate mofetil (MMF) regimen in a randomized, phase II clinical trial in adults with
hematologic malignancies undergoing myeloablative alloHCT. We hypothesize that substitution of VIC-1911 for
MMF will result in a significantly better 1-year graft-versus-host disease-free, relapse-free survival (GRFS),
setting a new standard in the field. Preclinical and phase I human data from the University of Minnesota show
significant promise in the combined PTCy/SIR/VIC regimen, with low rates of acute/chronic GVHD and relapse,
while not adding significant patient burden or side effects to the GVHD prophylaxis regimen. Partnering with
the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) will provide a robust platform for trial
implementation, capitalizing on their expertise, multicenter collaborative infrastructure, and access to a large
and diverse patient population, ensuring rigorous evaluation of our innovative regimen and its transformative
potential in the field of alloHCT. The University of Minnesota unequivocally affirms its commitment to the BMT
CTN, bringing its expertise and institutional resources to further enhance its mission and objectives through
clinical trials such as the one we propose herein.

## Key facts

- **NIH application ID:** 10938397
- **Project number:** 2UG1HL069290-24
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Christen Layne Ebens
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $232,500
- **Award type:** 2
- **Project period:** 2001-09-30 → 2031-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10938397

## Citation

> US National Institutes of Health, RePORTER application 10938397, BMT CTN Core - University of Minnesota (2UG1HL069290-24). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10938397. Licensed CC0.

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