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Stomach Neoplasms / TNhYP217 CAR T Cells / Mesothelioma · Phase 1 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an active Phase 1 trial of TNhYP218 CAR T cells in participants with mesothelin-expressing solid tumors including mesothelioma. The trial is designed to establish the recommended phase 2 dose based on dose-limiting toxicity and to obtain preliminary response rate data; no results have yet been reported in this registry record.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Mesothelioma, Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Thymus Neoplasms, Colonic Neoplasms; age from 18 Years; to 120 Years. Intervention: 1/Dose Escalation; 2/Dose Expansion. n = 100. 1 site: United States.
This is a registry record for an active Phase 1 trial of TNhYP218 CAR T cells in participants with mesothelin-expressing solid tumors including mesothelioma. The trial is designed to establish the recommended phase 2 dose based on dose-limiting toxicity and to obtain preliminary response rate data; no results have yet been reported in this registry record.
This is a registry record with no reported results; no safety, toxicity, or efficacy data are available.
Clinicians should note this is an active early-phase trial for which no efficacy or safety results are yet available in this registry record. Interested patients with mesothelin-expressing advanced solid tumors may be candidates for enrollment pending results.
This is a Phase 1 dose-escalation trial registration with no reported results; it is designed to establish safety and recommended phase 2 dose, with preliminary efficacy assessment as secondary aims.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should note this is an active early-phase trial for which no efficacy or safety results are yet available in this registry record. Interested patients with mesothelin-expressing advanced solid tumors may be candidates for enrollment pending results.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06885697). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Mesothelioma, Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Thymus Neoplasms, Colonic Neoplasms. Interventions: DEVICE: mesothelin expression testing; BIOLOGICAL: TNhYP217 CAR T Cells; DRUG: fludarabine; DRUG: cyclophosphamide. Primary outcome measures: Establish the recommended phase 2 dose (RP2D) of TNhYP218 CAR T cells based on dose-limiting toxicity (DLT) of defined adverse events (AEs). , DLT assessment will occur in participants in the dose escalation cohort daily on days 0-4, on day 7, on day 21 and during week 4.; Determine the preliminary objective response rate of TNhYP218 CAR T cells in a limited number of participants with mesothelioma treated at the recommended phase 2 dose. , assessed based on imaging studies at weeks 4, 8, 12 then every 12 weeks through disease progression or week 108, whichever occurs first.. Brief summary: Background: Mesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN. Objective: To test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma. Eligibility: People aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment. Design: Participants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN. Participants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. Participant s T cells will be modified in a lab to produce TNhYP218 CAR T cells. Participants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment. TNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days. After discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy. Long-term follow-up will continue another 10 years....
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