UNC Lineberger is one of only a select few 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 seven clinical trials open that are investigating the use of CAR-T therapies. A general description of the trials, plus links to the full study protocols, are available online. Future plans call for opening clinical trials for patients with relapsed gliobastoma multiforme, ovarian cancer and mantle cell lymphoma.

Immuno-Oncology

During the past decade, research has shown that the immune system can be harnessed to treat multiple different types of cancer, including melanoma, lung, bladder, renal, head and neck cancers and Hodgkin’s lymphoma. Additionally, there is increasing interest in evaluating approaches to enhance the immune response in the treatment of patients with other forms of cancer.  Researchers at the UNC Lineberger Comprehensive Cancer Center in Chapel Hill have been at the forefront of both immuno-oncology scientific research and clinical studies. Currently, UNC Lineberger physicians have trials available using antibodies targeting immune checkpoints for patients with acute myelogenous leukemia, bladder cancer, lung cancer, and endometrial cancer.  Additionally, there are trials utilizing immune therapy for the treatment of patients with sarcoma. If you are interested in pursuing treatment on a clinical trial for these diseases please contact the UNC Lineberger Clinical Protocol Office.

Cell Manufacturing

UNC Lineberger opened its Advanced Cellular Therapeutics Facility in 2015. The facility, which is certified to use Current Good Manufacturing Practices as set by the FDA, is located approximately five miles off campus. Cellular therapy products are generated and expanded in this facility for patients receiving adoptive cell therapy for the treatment of cancer.

Referrals

If you wish to refer a patient or have questions about any of the clinical trials, please contact Catherine Cheng, 919-445-4208

Clinical Trials

Pediatric Trials

Relapsed/Refractory Neuroblastoma
LCCC1743-ATL: A Phase I Study of Autologous Activated T-cells expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients with Relapsed or Refractory Neuroblastoma

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)

Adult Trials

CD19+ Relapsed/Refractory B-cell Lymphoma
LCCC1813-ATL: A Phase I Study of Autologous Activated T-cells Targeting the CD19 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects with Relapsed/Refractory B-cell Lymphoma

Relapsed/Refractory Multiple Myeloma
LCCC1603-ATL: Phase I Study of the Administration of Autologous CAR-T Cells Targeting the CD138 Antigen for Relapsed/Refractory Multiple Myeloma

CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma
LCCC1606-ATL: Phase I Study of the Administration of T lymphocytes Co-Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed/Refractory CD30+ Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma

Relapsed/Refractory Acute Lymphoblastic Leukemia
LCCC1541-ATL: 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

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)

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