Auto Immune Cell Therapy Research

Overview

Cells make up every living organism. Inside each cell are genetic instructions that determine its type and function. Every individual has stem cells. Stem cells are immature cells that can divide and mature into different types of specialized cells. This process is called differentiation. During this process specific genes in the cell’s DNA are turned on or off. This guides the cell to become of a particular type and function. 

The immune system is composed of specialized cells, some of which produce  antibodies.  Antibodies are special molecules produced by the “B lymphocytes of our immune system that specifically recognize and bind to foreign agents such as bacteria or viruses to help us fight infections and protect us from cancer cells. Sometimes however, antibodies can be misdirected against our own proteins and are associated with autoimmune diseases.

Autoimmune Diseases and Cells 

Autoimmune diseases can cause cell damage by mistaking healthy cells and tissue as foreign. The immune system attacks those cells or tissue and causes inflammation. This is often triggered by genetic predisposition and environmental factors but the causes are often unknown. Environmental factors may include infections, viruses, injury, and some chemicals.

What is Cell Therapy?

Cell therapy involves transferring specific types of cells into a person to treat disease by repairing or replacing damaged cells or tissues. Many different cell types can be modified or engineered for use in therapy, depending on the condition being treated. Cell therapy using immune cells called T-lymphocytes can treat certain blood and bone marrow cancers, and has shown promising results in clinical trials to treat some autoimmune diseases.

Types of Cell Therapy

Autologous Cell Therapy

Autologous cells are usually blood collected from the person’s own body. The cells are then modified outside of the body, and returned to the blood by infusion or injected into tissues. Using the body’s own cells decreases the risk of an allergic-type of response to reject them. 

CAR T Cell Therapy

In this type of autologous cell therapy, T lymphocytes (a type of immune blood cell) are engineered to express a Chimeric Antigen Receptor (CAR) on their cell surface. This enables CAR-T cells to target and destroy specific cells that contribute to the autoimmune disease. 

Allogeneic Cell Therapy

Allogeneic cells are collected and derived from someone other than the person being treated. The source of these cells can come from a variety of sources such as healthy donors' cord blood, or cell banks of undifferentiated cells. Allogeneic cells are often genetically engineered to improve their function.

NK Cell Therapy

Is a type of allogeneic cell therapy. NK cells are natural killer cells that target and eliminate autoreactive cells.  

How are cells collected from my body for autologous cell therapy?

In a process called apheresis, blood is run through a machine that separates its components, collects the desired blood cells, and returns the rest of the blood to the body.  In a similar process known as leukapheresis, some of a person’s white blood cells (leukocytes) are harvested. 

Pretreatment

Before receiving cell therapy a patient may need a conditioning regimen to decrease the immune system’s activity and prepare the body to accept the cells after they are infused. This process usually involves low-dose chemotherapy. If the trial you are interested in requires chemotherapy, this process will be explained to you in detail.

How are the modified cells administered?

They are introduced into the body by an infusion which can be administered intravenously (with an IV) or a peripherally inserted central catheter (PICC) line placement. PICC lines can be placed in an outpatient setting. Some cells may need to be injected directly into tissues.

Lifestyle Restrictions

Some cell therapy treatments require temporary lifestyle restrictions to ensure safety of the patient and monitoring for possible adverse reactions. These usually include avoiding driving and staying close to the medical facility immediately after cell infusion. Some trials may help decrease the burden of these restrictions. Your research care team will share these details with you.

Who is on my research care team?

A variety of individuals work together to provide your care, including your physician (an expert in your autoimmune disease), a cell therapy physician, a cell therapy research nurse, and a research coordinator.

Pose these questions to your care team:

1. Does this trial use my cells (autologous) or use donor cells (allogenic)?
2. Does this trial require chemotherapy treatment? If so, what does this process include?
3. Does this trial require a PICC line placement?
4. What are the lifestyle restrictions for this trial? Does the trial provide assistance with these restrictions?

New Non-Oncology Cell Therapy Trials

All non-oncology clinical trials involving cell therapy are required to submit trial protocols to the Autoimmune Cell Therapy (ACT) Research Hub for review. The ACT Research Hub will evaluate the level of involvement by the BMT group and, when appropriate, provide feedback regarding safety considerations and related requirements. Working with ACT Research Hub ensures alignment with established institutional workflows and standards. Resources, guidance, and support are available to study teams through the Hub.  

Here is the new trial intake form. Once received, we will grant you access to the Box account's resources and logistics information and request a meeting with you. Questions? Please contact [email protected]. 

Upcoming Webinars

Presented by: Dr. Parastoo Fazeli, MD

Topic: Her experience treating participants with lupus and scleroderma with an allogenic CAR-T

When: June 23, 2026, 12-1pm

Where: Zoom

Past webinars

Expanding Cell Therapy from Cancer to Autoimmunity: Horizons and FACTs presented by Dr. Bachanova, MD

FACT and CAR-T Therapy: Potential AEs and Supportive Care Recommendations presented by Dr. Juckett, MD and Dr. Hu, MD

Can we cure Lupus Nephritis? presented by Nephrologist, Wexner Medical Ctr., The Ohio State University

To receive webinar invitations or to access Box to view past webinars, please email [email protected].

ACT Primary Investigator Meetings

To receive an invitation to attend our regular Primary Investigator meetings for PIs, please email [email protected]. 

ACT Resources 

The ACT Toolkit Box Folder is most useful for study teams (coordinators, regulatory specialists, project managers, etc). It is updated regularly with guidance on topics like IBC submission, research lab kit processes, SOPs for working with Fairview and the CSC, and more. 

The ACT PI and BMT/CT Co-I Toolkit Box Folder is for PIs and BMT/CT Co-Is, with resources geared towards those roles. To gain viewing access to a folder, email [email protected].

Autoimmune Cell Therapy Faculty Members 

The committees are composed of a diverse group of individuals with expertise in research, various autoimmune diseases, and cell therapy. They shape the direction of the research hub by guiding decisions regarding which studies should be prioritized, and conducted, ensuring that they contribute to advancing scientific knowledge, improving patient outcomes, and supporting translational and clinical research in cellular therapy for autoimmune indications.   

 

 

 

 

Adam Carpenter, MD

Associate Professor and Multiple Sclerosis Division Director

 

 

Andrew Adams, MD

Professor and Chief, Division of Transplantation

 

 

 

 

 

Anne Blaes, MD

Director and Professor of Medicine, Division of Hematology, Oncology and Transplantation

 

 

Dan Mueller, MD

Professor of Medicine, Division of Rheumatic and Autoimmune Diseases

 

 

 

 

 

David McKenna, MD

Professor, Laboratory Medicine and Pathology

 

 

David Pearson, MD

Associate Professor, Dermatology  

 

 

 

 

 

Georgios Manousakis, MD

Associate Professor; Fellowship Director, Neuromuscular Medicine

 

 

Hyun Kim, MD

Professor, Pulmonary, Allergy and Critical Care Faculty

 

 

 

 

 

Jeffrey Miller, MD

Professor of Medicine, Division of Hematology, Oncology and Transplantation

 

 

Jerry Molitor, MD

Professor of Medicine, Division of Rheumatic and Autoimmune Diseases 

 

 

 

 

 

Joshua Rhein, MD

Assistant Professor, Division of Infectious Diseases and International Medicine

 

 

Mark Juckett, MD

Professor of Medicine Division of Hematology, Oncology, and Transplantation

 

 

 

 

 

Noah Goldfarb, MD

Associate Professor, Dermatology 

 

 

Parastoo Fazeli, MD

Associate Professor of Medicine, Division of Rheumatic and Autoimmune Diseases 

 

 

 

 

 

Peter Kang, MD

Professor and Vice Chair of Research

 

Autoimmune Cell Therapy Clinical Collaborators

 

 

 

 

Christine Wendt, MD

Professor of Medicine 

 

 

Holly Boyer, MD

Associate Professor

 

 

 

 

 

 

 

Jill Cordes

BSN, RN, CHRC; Director, Research Administration, Fairview Health Services 

 

 

 

 

 

To refer a patient to one of the open trials, please contact [email protected]. Please include the diagnosis of the patient and which trial you are referring to. The corresponding study team will reach out to you for more information.

Why work with us?

The Autoimmune Cell Therapy Research Hub at the University of Minnesota is committed to accelerating the development and delivery of innovative cell-based therapies for autoimmune diseases. We create the environment and infrastructure to conduct cell therapy clinical research in collaboration with pharmaceutical and biotechnology industries and with leading academic institutions .

The Autoimmune Cell Therapy Research Hub combines our deep expertise in immunology, cell therapy,clinical trial infrastructure, and regulatory navigation with the resources and innovation capacity of our partners. Together, we bring next-generation therapies to patients. Our uniquely integrated environment spans basic research, translational science, and clinical implementation; making us an ideal partner for sponsors seeking experienced trial sites and scientific collaborators. 

If you are a sponsor or academic institution interested in partnering with the Autoimmune Cell Therapy Research Hub on a trial, please complete the partnership intake form. Questions? Contact [email protected]

The following clinical trials are open to enrollment. More trials are in process so please check back soon. If you are interested in a study, please email, [email protected]. In the subject line please include the name of the principal investigator of the trial. This will ensure that your email is routed to the appropriate study team.  

Dermatology 

Official title: A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases 

Target disease: Idiopathic Inflammatory Myopathies 

Brief summary: This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases. 

Principal Investigator: Dr. David Pearson, MD

Link for more information on ClinicalTrials.gov

Nephrology 

Official title: A Phase 1/2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus

Brief summary: RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

Principal Investigator: Dr. Patrick Nachman, MD

Link for more information on ClinicalTrials.gov

Neurology

Official title: A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

Target Disease: myasthenia gravis 

A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy. 

Principal investigator: Georgios Manousakis, MD 

Link to more information on Clinicaltrials.gov

Pulmonology 

Official title: A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis 

Target Disease: Diffuse Cutaneous Systemic Sclerosis 

Brief summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab. 

Principal investigator: Hyun Kim, MD 

Link to more information on ClinicalTrials.gov

Rheumatology 

Official title: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Brief summary: This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate to severe active systemic lupus erythematosus (SLE), antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Principal Investigator: Dr. Parastoo Fazeli, MD

Link to more information on ClinicalTrials.gov

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis 

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. 

Principal Investigator: Dr. Daniel Mueller, MD

Link to more information on ClinicalTrials.gov

Rheumatology-Pediatric 

Official title: A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Brief summary: This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate to severe active systemic lupus erythematosus (SLE), antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Investigator: Dr. Bryce Binstadt, MD

Link to more information on