Clinical Trial 21113
A Phase I Clinical Trial of an Infusion of Autologous T Cells Genetically Engineered with a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients with Recurrent Ovarian Cancer
Disease Site: Ovary
Shaping the Future of Cancer Care
Moffitt Cancer Center is changing the landscape of cancer care through cell therapy. With a strong emphasis on translating scientific discoveries into effective treatments, Moffitt has developed groundbreaking therapies that harness the power of the immune system to target and eliminate cancer cells.
The field has grown exponentially since the first CAR T therapies were approved in 2017. Moffitt was pivotal in the clinical trials that led to several FDA approvals for cell therapies and continues to grow its capabilities in this field.
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180+
patients treated with TIL therapy
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2,000+
patients treated with CAR T therapy
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15+
years of cell therapy manufacturing experience
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90+
open immunotherapy trials
Setting the Standard for Cellular Therapy through Clinical Trials
Moffitt is rapidly translating leading-edge cellular therapy clinical trials into innovative standard of care treatments. As a respected pioneer of many novel cancer therapies, Moffitt coordinates the development of cell therapy clinical trials on a national level.
Clinical Trial 22557
A Phase 2, Open-Label, Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in Patients with Relapsed or Refractory Mantle Cell Lymphoma
Disease Site: Mantle Cell Lymphoma
PI: Jain, Michael
Clinical Trial 21027
A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer
Disease Site: Lung, Non small cell lung cancer
PI: Benjamin Creelan
Advancing TIL Therapy from Concept to FDA-Approval
The National Cancer Institute has been studying TIL therapy since the 1980s. After Moffitt researchers visited the institute to learn the protocol in 2009, Moffitt became the first cancer center outside of the institute to offer TIL to melanoma patients. This work led to the 2024 FDA approval of the first TIL therapy for advanced melanoma.
Now that the first TIL product is approved, Moffitt experts are exploring ways to optimize the treatment, and discovering opportunities to apply this groundbreaking treatment to other cancer types.
180+
Moffitt has opened 8 TIL trials, treating about 180 patients with TILs total.
Treating over 2,000 patients with CAR T isn’t just about advanced medicine. It’s about fostering hope, pushing boundaries, and redefining possibilities for a brighter future.
Dr. Ciara Freeman
Medical Oncologist, Blood and Marrow Transplant and Cellular Immunotherapy Program
Driving Advancements in CAR T Therapy
Moffitt played a crucial role in the landmark 2017 FDA approval of Yescarta. The ZUMA-1 clinical trial that led to this approval was co-led by Moffitt's Dr. Fredrick Locke and solidified Moffitt's position at the forefront of CAR T therapy.
Since this initial success, Moffitt continues to achieve significant breakthroughs in CAR T therapy with numerous clinical trials that have led to FDA approvals for lymphoma, leukemia, and multiple myeloma, expanding treatment options for patients.
As one of the select few centers certified to offer CAR T cell therapies for all approved indications, Moffitt is also the first cancer center worldwide to treat over 2,000 patients with CAR T therapy. By continually developing new and improved strategies, Moffitt strives to offer patients the most advanced and effective therapies available.
If you would like to learn more about Immunotherapy at Moffitt, or would like assistance in referring a patient for cell therapy, please email Physician.Relations@Moffitt.org. We are happy to partner with you!
Decades of Experience
Moffitt clinicians and researchers recognized the exceptional promise of cell therapy and the impact it could have on cancer patients early on. We have been actively involved in immunotherapy research and treatment for decades and have achieved significant milestones and advancements throughout this period.
Cell Therapy & Gene Engineering Facility
Launched in 2006, Moffitt's Cell Therapy & Gene Engineering Facilty offers comprehensive experience across a range of cell types, viral vectors, techniques and assays. Our expertise in the product development and cGMP manufacturing supports accelerated IND filing, support for CMC preparation and faster turnaround for clinical trial amendments.
Immune Cell Therapy Unit
Opened in 2020, the Immune Cell Therapy Unit was exclusively designed for cell therapy treatments. It features 12 inpatient beds and eight treatment bays for outpatient visits, including the preparatory chemotherapy needed to make room for newly super-chared immune cells. Patients come to the same place - and see the same team - from start to finish for their cell therapy treatment.
A PACT Site
Moffitt was selected as a Cell Processing Facility offering translational services and cell product manufacturing for pre-clinical studies to investigators at no charge under the National Heart, Lung, and Blood Institute-funded Production Assistance for Cellular Therapies (PACT) program.
We now have patients, who had no other viable treatment options at the time, who are in ongoing complete remission after a single infusion of CAR T cells.
Frederick Locke
Chair and Senior Member, BMT and Cellular Immunotherapy Leader, Cellular Immunotherapy Program
TIL therapy is the most reliable option after traditional standard-of-care therapies have failed. We are not going to stop here. We aren't going to be satisfied with what we have now. We are greedy in terms of wanting better responses for patients.
Amod Sarnaik, MD
Cutaneous Surgical Oncologist
Patrick Hwu, MD
President and CEO
Frederick Locke, MD
Program Co-Leader, Immuno-Oncology; Chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy
Daniel Abate-Daga, PhD
Associate Member, Immunology
Nelli Bejanyan, MD
Program Leader, Blood and Marrow Transplant and Cellular Immunotherapy
Tiago Biachi, MD, PhD
Associate Member, Gastrointestinal Oncology
Christine Chung, MD
Chair, Head Neck & Endocrine
Mihaela Druta, MD
Vice Chair, Sarcoma
Ciara Freeman, MD, PhD
Assistant Member, Department of Blood and Marrow Transplant and Cellular Immunotherapy
Elsa Flores, PhD
Associate Center Director, Basic Science
Peter Forsyth, MD
Chair, Neuro-Oncology
Doris Hansen, MD
Assistant Member, Department of Blood and Marrow Transplant and Cellular Immunotherapy
Alex Jaegar, RS BS
Assistant Member, Molecular Oncology
Lilit Karapetyan, MD
Assistant Member, Cutaneous Oncology
Roger Li, MD
Associate Member, Genitourinary Oncology
James Mulé
Associate Center Director, Translational Science
John Mullinax, MD
Section Head, Surgical Oncology, Sarcoma Department
Amod Sarnaik, MD
Surgical Oncologist
Greg Sawyer, PhD
Chair, BioEngineering
Kenneth Tsai, MD PhD
Vice Chair, Research Pathology
Dae Won Kim, MD
Associate Member, Gastrointestinal Oncology
