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MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
Recruiting
The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.
Male or Female
18 years and over
Inclusion Criteria:
• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)
Drug: Bendamustine, Drug: Cetuximab, Drug: Cisplatin, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: FT825, Drug: Fludarabine
Cancer
Clinics and Surgery Center (CSC), Metastatic Cancer, Solid Tumor Cancer
Manish Patel - patel069@umn.edu
Manish Patel
PHASE1
SITE00002088
See this study on ClinicalTrials.gov