Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer

Study Name
	Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer
ClinicalTrials.gov Identifier (if applicable)
	NCT03907852
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Other Novel Therapy
Study Center
Institution Name
	National Cancer Institute
Institution Address
	9000 Rockville Pike
City
	Bethesda
State
	Maryland
Zip Code
	20892
Country
	United States
Phone
	(240) 858-3159
Website
	https://clinicaltrials.gov/ct2/show/NCT03907852
Study Contacts
Principal Investigator
	Raffit Hassan
P.I. Phone
	(240) 858-3159
P.I. Email
	Cathy.wagner@nih.gov
Study Coordinator
	Cathy Wagner
Study Coordinator Phone
	(240) 858-3159
Study Coordinator Email
	Cathy.wagner@nih.gov
List additional Study Coordinators (include phone number and email)
	Donna Mabry 240-858-3155 donna.mabry@nih.gov
OVERVIEW – in layman’s terms (150 words max)
	TC-210 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.
Enrollment
	open
Study Start Date
	04/09/2019
Estimated Completion Date
	4/1/2026
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently determine an overall response rate in patients with advanced mesothelin-expressing cancers. This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently determine an overall response rate in patients with advanced mesothelin-expressing cancers.
Inclusion Criteria – Patients Must:
	Patient is > 18 years of age at the time the Informed Consent is signed. Patient has a pathologically confirmed diagnosis of Cholangiocarcinoma. Patient’s tumor has been pathologically reviewed by the central laboratory with confirmed positive MSLN expression on > 50% of tumor cells that are 2+ and/or 3+ by immunohistochemistry. Prior to TC-210 T cell infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease with more details provided in the clinical protocol Patient has an Eastern Cooperative Oncology Group performance status 0 or 1. Patient has a left ventricular ejection fraction > 45% as measured by resting echocardiogram, with no clinically significant pericardial effusion. Patient is fit for leukapheresis and has adequate venous access for the cell collection. Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Tumor has to be tested by NCI central laboratory and have confirmed MSLN expression on more than 50% of tumor cells