# ALT-803 (IL-15/IL-15Rα-Fc) maintenance after allogeneic transplantation for AML

> **NIH NIH UG1** · UNIVERSITY OF MINNESOTA · 2021 · $184,800

## Abstract

Project Summary/Abstract
The University of Minnesota has been highly committed to The BMT CTN. Our expertise on alternative donors
and graft-vs-host disease served as the basis for successful Network studies. Our participation in the Network
includes a past-Steering Committee chair, national PIs on six protocols, leading roles in Network publications
and committing institutional resources to develop and successfully execute Network trials. Our proposal
addresses the risk of acute myeloid leukemia (AML) relapse after reduced intensity allogeneic hematopoietic cell
transplantation (HCT), which remains the main cause of treatment failure. Our institutions long-lasting interest
on natural killer (NK) cell biology as a critical mediator of the graft-versus-tumor/leukemia (GVL) effect led to the
development of this platform using ALT-803, a soluble complex consisting of two protein subunits of a human
IL-15 variant associated with high affinity to a dimeric human IL-15 receptor α (IL-15Rα) sushi domain/human
IgG1 Fc fusion protein enhancing NK cell specificity and half-life. Our hypothesis is that stimulating the innate
immune system with ALT-803 will reduce the cumulative incidence of relapse and improved probability of
relapse-free survival (RFS), after reduced intensity conditioning (RIC) HCT. In early clinical trial studies we
demonstrated the safety and established side effect profile of ALT-803 when given to patients with advanced
hematological malignancies, including post-allogeneic HCT. A phase 2 study on ALT-803 administration as
maintenance after reduced intensity allogeneic HCT for AML and myelodysplastic syndrome is in the last steps
of regulatory approval and will provide further data on the safety and feasibility of the post-transplantation
maintenance approach. The primary objective of the proposed the phase 3 randomized placebo-controlled
clinical trial in this proposal is to determine if ALT-803 improves the probability of disease-free survival as
maintenance after reduced intensity allogeneic HCT for AML in first complete remission. The administration of
immune modulatory agents such as ALT-803 aiming reducing the risk of relapse and improve outcomes after
HCT is one of many potentially practice changing strategies that require confirmation on a multicenter
randomized clinical trial, which is part of the BMT CTN mission. Our institution's continued commitment to the
Network's success is not only reflected in developing new protocols, but alos continued internal process to better
support regulatory, enrollment and sample collection requirements Network clinical trials.

## Key facts

- **NIH application ID:** 10188587
- **Project number:** 5UG1HL069290-21
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** DANIEL J WEISDORF
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $184,800
- **Award type:** 5
- **Project period:** 2001-09-30 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10188587

## Citation

> US National Institutes of Health, RePORTER application 10188587, ALT-803 (IL-15/IL-15Rα-Fc) maintenance after allogeneic transplantation for AML (5UG1HL069290-21). Retrieved via AI Analytics 2026-06-10 from https://api.ai-analytics.org/grant/nih/10188587. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*