What is TNhYP218 CAR T cell therapy studying for mesothelioma and other solid tumors?

This study is evaluating TNhYP218 CAR T cells, a new immune-based treatment designed to target tumors with high levels of mesothelin protein. Researchers aim to find the best dose and assess early responses in adults with mesothelioma and other mesothelin-expressing cancers. The National Cancer Institute sponsors this trial to explore this innovative therapy.

Who may be eligible for this mesothelioma clinical trial?

Adults 18 years and older with mesothelioma or other solid tumors expressing mesothelin who have experienced progression after standard treatments may be eligible. Participants should have good organ function and a performance status of 0 or 1. Please review eligibility criteria for more details.

Is there any cost to participate in this mesothelioma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Age: 18Years - 120Years

All Genders

ID06885697

Phase 1 Trial of TNhYP218 CAR T Cells Targeting Mesothelin in Adults with Mesothelioma and Other Solid Tumors

Led by National Cancer Institute (NCI) · Updated on 2026-08-11

100

Participants Needed

Research Sites

521 weeks

Total Duration

AI-Summary

What this Trial Is About

This research evaluates a new treatment using genetically modified T cells, called TNhYP218 CAR T cells, for adults with mesothelin-expressing solid tumors, including mesothelioma. Mesothelioma is an aggressive cancer affecting the linings of organs, and mesothelin is a protein found in high amounts in many tumors. The study aims to test the safety, dosing, and preliminary effectiveness of this immune-based therapy in people whose tumors have returned or spread after standard treatments. Participants will first undergo screening including a biopsy to check mesothelin levels in their tumors. They will have their own T cells collected through a blood process called leukapheresis. These T cells are then modified in a laboratory to target mesothelin. Before receiving the treatment, participants will be given chemotherapy drugs to prepare their bodies. The modified T cells are infused intravenously, and participants will stay in the hospital for about a week after infusion. The study includes a dose-escalation phase and a dose-expansion phase to find the recommended dose and assess response. During the study, participants will have regular follow-up visits for up to 15 years to monitor safety and treatment effects. These visits may include imaging scans, blood tests, heart function tests, and additional biopsies. Researchers will closely watch for side effects, tumor response, progression-free survival, and overall survival. The total participation time includes treatment, hospital stay, and long-term monitoring to evaluate the therapys impact over many years.

CONDITIONS

Brief Title

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Who Can Participate

Age: 18Years - 120Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Diagnosis of unresectable, locally advanced, metastatic, or recurrent mesothelioma or other mesothelin-expressing solid tumors
For mesothelioma, only epithelioid or biphasic histology with >80% epithelioid component
Progressed after at least one FDA-approved systemic therapy for their tumor
At least one measurable lesion by RECIST version 1.1
Tumor mesothelin positivity of 2+ to 3+ in ≥50% of cancer cells
ECOG performance status of 0 or 1
Adequate organ and marrow function as defined by specific laboratory values
Normal cardiac ejection fraction (≥45%) and no significant pericardial effusion
Room air oxygen saturation ≥90%
Resolved treatment-related toxicities to ≤ grade 2
Stable, asymptomatic CNS metastases with no corticosteroids for at least 4 weeks prior
Agreement to use effective contraception or abstinence if of childbearing potential
Agreement to discontinue nursing during study therapy and for specified time after
Ability to understand and sign informed consent

You will not qualify if you...

Prior systemic therapy, investigational therapy, radiation, or surgery within 14 days before leukapheresis or 21 days before lymphodepleting chemotherapy
Prior anti-PD-1 or anti-PD-L1 therapy within 8 weeks before treatment initiation
Primary immunodeficiency or active/history of autoimmune or immune-mediated diseases (except controlled endocrine deficiencies and vitiligo)
History of severe immediate hypersensitivity to cyclophosphamide or fludarabine
Use of therapeutic systemic corticosteroids within 14 days before treatment (physiologic doses allowed)
Lung fibrosis, inflammatory lung disease, or pneumonitis on imaging or history
Other prior or concurrent malignancy except certain treated cancers in remission
QTc interval >450 msec in males or >470 msec in females on ECG
Active infection with HIV, hepatitis B or C, or HTLV
Pregnancy or intent to become pregnant during required contraception period
Live or attenuated vaccine within 30 days before treatment
History of seizure disorder unless due to treated metastatic lesions
Ongoing uncontrolled illness or active infection impacting safety or compliance

Research Team

Maria Gracia L Agra, R.N.

Raffit Hassan, M.D.

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 1 Trial of TNhYP218 CAR T Cells Targeting Mesothelin in Adults with Mesothelioma and Other Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria