Key Research Initiatives & Enrollment Opportunities
Dendritic Cell Vaccine Trial for HER2+ Breast Cancer
Led by Dr. Heather Han, Moffitt is the only site enrolling patients in a novel HER2-primed dendritic cell vaccine trial (NATASHA). This personalized immunotherapy approach aims to reduce chemotherapy use and improve outcomes for early-stage HER2-positive breast cancer. Early results show tumor shrinkage before chemo begins.To refer an eligible patient for the NATASHA trial, please email the Clinical Trial Coordinator at CTOBreast@Moffitt.org.
Principal Investigator: Hyo Han, MD
CAR T-Cell Therapy for Recurrent Ovarian Cancer
Moffitt is leading a first-of-its-kind clinical trial offering CAR T-cell therapy for patients with recurrent ovarian cancer. This personalized treatment targets the follicle stimulating hormone receptor (FSHR), which is uniquely expressed on ovarian cells. Administered intraperitoneally via a surgically placed catheter, the therapy is designed to directly reach tumor sites while minimizing systemic toxicity. Moffitt was the first center to secure FDA approval to offer a second round of CAR T for a patient who responded to initial treatment, highlighting the potential for durable benefit in a disease with limited options.
Principal Investigator: Robert Wenham, MD
CAR T-Cell Therapy vs Standard of Care in Relapsed/Refractory Multiple Myeloma
Moffitt is enrolling patients in a Phase 3 clinical trial evaluating anitocabtagene autoleucel, a BCMA-directed CAR T-cell therapy, versus standard of care in relapsed/refractory multiple myeloma. This randomized study will assess progression-free survival, safety, patient-reported outcomes, and long-term durability of response in patients who have received 1 to 3 prior lines of therapy. Eligible patients must have measurable disease and prior treatment with an IMiD and anti-CD38 antibody.
Principal Investigator: Ciara Freeman, MD, PhD
CAR T Therapy for MRD+ Large B-Cell Lymphoma After First-Line Treatment
Moffitt is enrolling patients in a Phase 3 study evaluating cemacabtagene ansegedleucel (cema-cel), an allogeneic CAR T-cell therapy, versus observation in patients with minimal residual disease (MRD+) after first-line treatment for large B-cell lymphoma (LBCL). This is the first randomized trial investigating CAR T for MRD+ disease in patients who achieved a partial or complete response following standard first-line therapy. Patients must prescreen for MRD and meet imaging and eligibility criteria prior to randomization.
Principal Investigator: Frederick Locke, MD
CAR T-Cell Therapy for Metastatic Castration-Resistant Prostate Cancer
Moffitt is conducting a Phase 1 trial of autologous gamma delta T cells genetically engineered with a chimeric receptor to target the prostate stem cell antigen (PSCA) in patients with metastatic castration-resistant prostate cancer. The primary goal is to evaluate safety and determine the recommended Phase 2 dose, with secondary measures assessing preliminary efficacy. This personalized approach is designed to direct modified immune cells against prostate tumors while minimizing off-target effects. Slots are currently available for eligible patients.
Principal Investigator: Jingsong Zhang, MD, PhD
TCR Therapy vs Standard of Care for Metastatic Melanoma
Moffitt is enrolling patients in a Phase 3 randomized study comparing IMA203, a TCR-engineered T-cell therapy targeting MAGE-A4, versus investigator’s choice of standard treatment (TIL therapy or chemotherapy) for unresectable or metastatic cutaneous melanoma. Patients must be HLA-A*02:01 positive and have progressed on prior PD-1 therapy, with BRAF-positive patients also having received BRAF-directed therapy unless otherwise contraindicated. The trial will assess overall efficacy, safety, and quality of life outcomes, with prescreening for HLA status required before enrollment.
Principal Investigator: Lilit Karapetyan, MD, MS, FACP
*Last Updated 8/2025
