TriangleNCT05451849 · REGISTRY CONDITION SEARCH
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE1, PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2026-07-13
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells
- intervention Names
- Biological: TC-510
- Drug: Fludarabine
- Drug: Cyclophosphamide
- label
- Lymphodepletion followed by TC-510
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Lymphodepletion followed by TC-510
- description
- TC-510
- name
- TC-510
- type
- BIOLOGICAL
- arm Group Labels
- Lymphodepletion followed by TC-510
- description
- Fludarabine
- name
- Fludarabine
- type
- DRUG
- arm Group Labels
- Lymphodepletion followed by TC-510
- description
- Cyclophosphamide
- name
- Cyclophosphamide
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 14
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event
- measure
- Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
- time Frame
- From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
- secondary Outcomes
- description
- ORR is the proportion of patients with a Complete Response (CR) or Partial Response (PR) via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
- measure
- Overall Response Rate (ORR)
- time Frame
- From first TC-510 infusion through study completion (up to approximately 38 months)
- description
- DCR is defined as the ORR plus the proportion of patients with Stable Disease (SD) for at least 8 weeks via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
- measure
- Disease Control Rate (DCR)
- time Frame
- From first TC-510 infusion through study completion (up to approximately 38 months)
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- Malignant Mesothelioma
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- source file
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- Small Intestine Cancer
- query disease state id
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- source file
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Preserved source evidence · Not medical advice