A Phase I Clinical Trial of Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

Trial ID #	NCT02498912
Phase	I
Drug Class	Immunotherapy: Cellular Therapy
Drug Name	4H11-28z/fIL-12/EFGRt+ CAR T
Alternate Drug Names	4H11-28z/fIL-12/EFGRt+ genetically-modified T cells, autologous MUC16ecto-targeting EGFR-secreting T lymphocytes
Drugs in Trial	4H11-28z/fIL-12/EFGRt+ CAR T, Cyclophosphamide, Fludarabine
Eligible Participant	MUC16ecto+ recurrent high grade serous ovarian cancer (> 2 prior therapies)
Patients Enrolled	18
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, evaluated per RECIST
Efficacy	DCR: 44% (8SD, n=18)
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE:
Conclusion	IV and IP CAR T cell therapy is safe in the absence of chemotherapy, but toxicity is observed when the CAR T cells are given post-lymphodepleting chemotherapy
Reference	O'Cearbhaill RE et al: A phase I clinical trial of autologous chimeric antigen receptor (CAR) T cells genetically engineered to secrete IL-12 and to target the MUC16ecto antigen in patients (pts) with MUC16ecto+ recurrent high-grade serous ovarian cancer (HGSOC). SGO (2020) abstract 54 https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/16374