Clinical trial · Interventional
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants were enrolled in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Mesothelioma, Malignant | Malignant Mesothelioma | ALIAS | 0.90 |
| Mesothelioma Peritoneum | — | UNRESOLVED | — |
| Mesotheliomas Pleural | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| TC-510 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymphodepletion followed by TC-510
- description
- Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells
- interventionNames
- Biological: TC-510
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
- timeFrame
- From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available