Clinical trial NCT05451849: A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
Official title: A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Mesothelioma
Mesotheliomas Pleural
Mesothelioma, Malignant
Mesothelioma Peritoneum
Ovarian Cancer
Ovarian Serous Adenocarcinoma
Pancreatic Cancer
Pancreatic Adenocarcinoma
Colorectal Cancer
Triple Negative Breast Cancer
TNBC - Triple-Negative Breast Cancer
Ovarian Adenocarcinoma
Pancreatic Neoplasms
Colorectal Neoplasms
Ovarian Neoplasms
Cholangiocarcinoma
Non Small Cell Lung Cancer
Lead sponsor: TCR2 Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, 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 and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.


Eligibility criteria: Inclusion Criteria:

* Patient is \> 18 years of age at the time the Informed Consent is signed.
* Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
* Patient's tumor has been reviewed with confirmed positive MSLN expression on \>/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. Patients with epithelioid MPM, confirmation of MSLN expression is not required prior to enrollment.
* Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
* Patients has an ECOG performance status 0 or 1
* 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

Exclusion Criteria:

* Inability to follow the procedures of the study
* Known or suspected non-compliance, drug, or alcohol use

Primary outcomes:
measure: Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
timeFrame: DLTs within 28 days post-treatment
measure: Phase 2 - Overall Response Rate (ORR)
timeFrame: Up to 2 years post-treatment
measure: Phase 2 - Disease Control Rate (DCR)
timeFrame: Up to 2 years post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Bethesda
country: United States
facility: National Cancer Institute
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota, Masonic Cancer Center
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Einstein Cancer Center
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
Study officials:
References: