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Cell Therapy and Gene Therapy

The Duke Center for Cell and Gene Therapy offers the most advanced cell and gene therapies available today. Cell and gene therapies are biologic treatments that change or replace your body’s cells or genes to treat cancers and rare genetic disorders. Our team has been involved in many of the clinical trials that led to FDA approval of these therapies and is shaping the future of these treatments.

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Conditions Treated with Cell and Gene Therapies

Cell Therapy

Cell therapies replace or modify certain cells of your body. First, blood or other tissue is removed from your body. Next, certain cells are removed and re-engineered in a specialized manufacturing facility and returned to your body through an infusion. Sometimes blood comes from a donor, and is not removed from your body.

In hematopoietic stem cell transplants (also known as bone marrow transplants; cord blood transplants are also a type of stem cell transplant), cancer cells in your bone marrow are first destroyed by chemotherapy or radiation. Next, healthy stem cells are collected from your body or a donor, and infused back into your blood so that the bone marrow can produce healthy, cancer-free blood.

TIL (Tumor-Infiltrating Lymphocytes) Therapy

This type of cell therapy extracts tumor-fighting T-cells from around a tumor. The cells are multiplied and activated to recognize and attack cancer cells. They are reinfused to help your immune system fight cancer. Examples include:

  • Amtagvi®(lifileucel) to treat melanoma.

TCE (T-cell Engager) Therapy

A form of immunotherapy, TCE therapy activates T-cells. It uses lab-made antibodies to connect T-cells to tumor cells and force them to attack and kill the tumor. Examples include:

  • Kimmtrak® (tebentafusp-tebn) to treat uveal melanoma.

  • Tecvayli® (teclistamab-cqyv) to treat multiple myeloma.

Gene Therapies

Gene therapy may be injected into an organ or tissue or given through an infusion. Some gene therapies use modified viruses that are engineered to carry modified genes into your cells. Gene therapies are often, but not always, designed as one-time treatments. Examples include:

  • Luxturna® (voretigene neparvovec), to treat inherited retinal disease.

  • Zolgensma® (onasemnogene abeparvovec-xioi) to treat spinal muscular atrophy.

  • Casgevy® (exagamglogene autotemcel) to treat sickle cell disease and transfusion-dependent beta thalassemia.
  • Lyfgenia™ (lovotibeglogene autotemcel) to treat sickle cell disease.
  • Zynteglo™ (betibeglogene autotemcel) to treat beta-thalassemia.

Cell-based Gene Therapies

CAR (Chimeric Antigen Receptor) -T therapy 

CARhe most common type of cell-based gene therapy. T-cells are extracted, genetically modified to recognize the cancer, and infused back into the blood to attack cancer cells. They are often used to treat blood cancers. Examples include:

  • Carvykti® (ciltacabtagene autoleucel) to treat multiple myeloma.

  • Aucatzyl® (obecabtagene autoleucel) to treat B-cell acute lymphoblastic leukemia.

TCR (T-Cell Receptor) Therapy 

removes T-cells from the blood. These T cells are then genetically modified to recognize proteins inside the cancer cells and multiplied. They are reinfused into the blood to find and eliminate cancer cells. Examples include:

  • Tecelra® (afamitresgene autoleucel) to treat synovial sarcoma.

Clinical Trials at Duke

Cord Blood-Based Cellular Therapy

Omidubicel® (omidubicel) is an FDA-approved, modified cord blood-based cell therapy that increases the number of stem cells in cord blood, allowing a single unit of blood to be sufficient for transplant. The time required for engraftment is nearly half that of a conventional cord blood-based stem cell transplant (an average of 12 days vs. 22 days). This results in a faster recovery, a lower risk of infection, and a shorter hospital stay. It is used to treat people 12 years and older with high-risk blood cancers, including:

  • Acute Lymphoblastic Leukemia

  • Acute Myeloid Leukemia

  • Chronic Myelogenous Leukemia

  • Lymphoma

  • Myelodysplastic Syndrome

Why Choose Duke

Leaders in Advanced Care

We were the first in the region to offer FDA-approved cellular therapies for solid tumors, including tumor-infiltrating lymphocyte (TIL) therapy for melanoma and engineered T-cell receptor (TCR) cell therapy for synovial sarcoma. We are also one of the few centers in the country to offer mesenchymal stromal cell (MSC) therapy for acute graft-versus-host disease in children.

Cord Blood Transplant Pioneered at Duke

The world’s first cord blood transplant with an unrelated donor was performed at Duke in 1993 in a pediatric patient. Three years later, unrelated cord blood was transplanted into an adult.

Deep Experience Offering Cellular Therapies

Duke specialists in cellular therapies treat over 140 people per year with cellular therapies such as CAR-T and TCR therapy. Though the treatments are newer, we have extensive experience taking care of people who need these life-saving therapies, including managing any side effects that may arise.

Treatment in an Outpatient Setting

The Blood Cancer Center’s Day Hospital is one of the few in the region equipped to administer stem cell transplants, cellular therapy, chemotherapy, and other blood products in a safe, outpatient setting. You may receive your treatment without being hospitalized and return home or to a nearby apartment every night during your therapy. The Day Hospital is staffed by a dedicated team that includes hematologic-oncologists, physician assistants, nurse practitioners, specialized pharmacists, and skilled nurses who specialize in monitoring you while you receive your treatment.

Family-Based Support 

We offer a variety of support services to you and your loved ones during treatment, including assistance with insurance coverage, local housing, support groups, counseling, and more.

FACT Accreditation

Duke is accredited by the Foundation for Accreditation for Cellular Therapy (FACT), meeting all quality and safety standards required to deliver these highly complex treatments. We also have an FDA-approved Risk Evaluation and Mitigation Strategy Program to address any risks and side effects associated with CAR T-cell therapy.

Commitment to Advancing the Field

Our researchers explore genetic differences among cancers that lead to improved therapies. Novel techniques such as less intense stem cell transplants, pioneered in part at Duke, offer hope to people with cancer.

Consistently Ranked Among the Nation’s Best Hospitals

Duke University Hospital is proud of our team and the exceptional care they provide. They are why we are recognized as the best hospital in North Carolina, and nationally ranked in 11 adult and 9 pediatric specialties by U.S. News & World Report for 2025–2026.

This page was medically reviewed on 06/04/2026 by
Mitchell E. Horwitz, MD | Cellular Therapy Specialist
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