Clinical Immunotherapy Program

UNC Lineberger is one of only seven academic centers in the United States – and the only center in North Carolina, Georgia, South Carolina, Tennessee and Virginia – with the scientific, technical and clinical capabilities to identify new tumor targets and then develop and infuse novel chimeric antigen receptor T-cell (CAR-T) immunotherapy. These therapies are manufactured at UNC Lineberger and are not commercially available. This makes it possible for people who live in or near the Southeastern U.S. to stay closer to home to undergo clinical immunotherapy treatment for cancer.


In 2015, UNC Lineberger Comprehensive Cancer Center undertook a major initiative to harness the power of a patient's immune system to fight cancer with the recruitment of Gianpietro Dotti, MD, and Barbara Savoldo, MD, PhD.  These two investigators bring more than a decade of experience in the use of adoptive cell therapy for the treatment of patients with cancer, with a particular focus on the design and implementation of chimeric antigen receptor (CAR) modified T cells.

Under the direction of Jonathan Serody, MD, Dotti and Savoldo, the UNC Lineberger's Clinical Immunotherapy Program currently has three clinical trials open that are investigating the use of CAR-T therapies. Two are for the treatment of patients with CD30+ lymphoma, and the other trial is for patients with CD19+ acute lymphoblastic leukemia. Future plans call for opening clinical trials for patients with relapsed multiple myeloma, glioblastoma multiforme or neuroblastoma.

Clinical Trials

UNC Lineberger Clinical Immunotherapy Program is conducting chimeric antigen receptor T-cell (CAR-T) clinical trials that are currently open for patient accrual. These experimental treatments involve re-engineering cells from the patient's immune system to recognize and direct the attack against the patient's cancer.

UNC Lineberger's Clinical Immunotherapy Program has a robust clinical trials program that currently has three trials open for patient accrual.

Program faculty are also in the process of developing several other study protocols, including  a trial for patients with relapsed multiple myeloma which is scheduled to open in 2018. Future trials that will target glioblastoma multiforme and neuroblastoma are expected to open by mid 2019.

Relapsed/Refractory Acute Lymphoblastic Leukemia

LCCC1541-ATL Phase I Study of the Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase9 Safety Switch in Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia. The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable and later to determine an optimal dose of AP1903 to be given to subjects to alleviate severe cytokine release syndrome or neurological complications from CAR T cell therapy. Principal Investigator: Matthew Foster, MD

CD30+ Lymphoma in patients undergoing autologous stem cell transplant

LCCC1524-ATL Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS). This study is available to patients with high-risk CD30+ lymphoma who are undergoing an autologous stem cell transplant as therapy. Study participants will receive high-dose chemotherapy and autologous stem cell transplant followed by infusion of autologous CAR T-cells directed against CD30. This study is designed to evaluate the safety of this therapy. Secondary endpoints evaluate the clinical activity of this treatment. Principal Investigator: Thomas C. Shea, MD

Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma

LCCC1532-ATL Phase Ib/II Study of the Administration of T lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma. Patients must be 18 years and older. This trial studies the efficacy of CAR T cells targeting CD30 in treating patients with relapsed/refractory CD30+ Hodgkin lymphoma or non-Hodgkin lymphoma that expresses CD30. Patients who have failed treatment with autologous or allogeneic stem cell transplantation are eligible for this therapy. Principal Investigator: Anne Beaven, MD