Anti-CD4 antibody–modulated transplants for GVHD prevention in hematopoietic cell transplantation

K Kristina Roth (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) D Dennis Loeffler (2Department of Medical Bioinformatics, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) C Conny Blumert (2Department of Medical Bioinformatics, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) A Alexander Scholz (2Department of Medical Bioinformatics, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) K Kristin Reiche M Marcus Bauer C Claudia Wickenhauser D Denise Schiefer (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) N Nadja Hilger (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) A André-René Blaudszun (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) J Jenifer Thees (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) J Jasmin Walter U U. Sandy Tretbar (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) U Ulrike Koehl (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) S Stephan Fricke (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany) U Ulrich Blache (1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany)

Abstract

Abstract Graft-versus-host disease (GVHD) remains one of the major complications following allogeneic hematopoietic cell transplantation. Currently, immunosuppressants are used for GVHD prophylaxis and treatment in most transplantation recipients. Due to their systemic, nonspecific mode of action, this treatment regimen is frequently associated with severe toxic side effects, opportunistic infections, as well as cancer relapse when treating hematologic malignancies. By using short-term ex vivo modulation of hematopoietic cell transplants with the anti-human CD4 antibody MAX.16H5, we have developed a novel immune tolerance–inducing strategy enabling potent GVHD prevention. Functional in vitro assays and transcriptome profiling data suggest impaired T-cell receptor signaling and a shift toward an interleukin-10–dependent regulatory phenotype as the primary mechanism of action of anti-human CD4 antibody treatment, leading to significantly reduced activation and proliferation of CD4+ and CD8+ T cells. A one-time incubation of hematopoietic transplants with MAX.16H5 prolongs survival of NSG (NOD.Cg-PrkdcSCID Il2rgtm1Wjl/SzJ) mice and reduces signs of GVHD manifestation as effectively as repeated application with clinically applied immunosuppressants, making it a safe and effective immunotherapy for GVHD prevention.

Article Details

Journal Blood
Volume / Issue Vol. 147, Issue 20
Published May 14, 2026
Pages 2402-2414
ISSN 0006-4971
Publisher Elsevier BV

Journal Info

Blood

Elsevier BV

ISSN: 0006-4971 Health Sciences

Authors (16)

K

Kristina Roth

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

D

Dennis Loeffler

2Department of Medical Bioinformatics, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

C

Conny Blumert

2Department of Medical Bioinformatics, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

A

Alexander Scholz

2Department of Medical Bioinformatics, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

K

Kristin Reiche

M

Marcus Bauer

C

Claudia Wickenhauser

D

Denise Schiefer

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

N

Nadja Hilger

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

A

André-René Blaudszun

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

J

Jenifer Thees

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

J

Jasmin Walter

U

U. Sandy Tretbar

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

U

Ulrike Koehl

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

S

Stephan Fricke

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

U

Ulrich Blache

1Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany