Merkel Cell Carcinoma clinical trials at UCSD

This Phase 1B/2 study is a multicenter, open-label, study of RP1 to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients. This will include patients with either previous renal, hepatic, heart, or lung allograft transplantation and experiencing subsequent documented locally advanced or metastatic cutaneous malignancies. The study will enroll a total of 65 evaluable patients. Patients will participate up to approximately 3 years including a 28-day screening period, up to approximately 1 year treatment period, and a 2-year follow-up period.

CMP-001-009 is a Phase 2 study of intratumoral CMP-001 in combination with an intravenous PD-1-blocking antibody administered to participants with certain types of advanced or metatastic cancer. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with a programmed cell death protein (PD-1)-blocking antibody in subjects with certain types of advanced or metatastic cancer. The secondary objectives are to: - To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with a PD-1-blocking antibody in study subjects. - To evaluate the efficacy of CMP-001 in combination with a PD-1-blocking antibody in study subjects. Participants will continue to receive treatment of CMP-001 in combination with a PD-1-blocking antibody according to the treatment schedule until a reason for treatment discontinuation is reached.

FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.

Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study. The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.