Actively Recruiting
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Led by National Cancer Institute (NCI) · Updated on 2026-02-17
100
Participants Needed
1
Research Sites
986 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Have unresectable, locally advanced, metastatic, or recurrent mesothelioma (epithelioid or biphasic with >80% epithelioid) or other mesothelin-expressing solid tumors
- Tumor positive for mesothelin in at least 50% of cancer cells by immunohistochemistry
- Progressed on at least one FDA-approved systemic therapy for their tumor type
- At least one measurable lesion by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (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 of 90% or greater
- Prior treatment-related toxicities resolved to grade 2 or less
- Stable, asymptomatic CNS metastases if applicable, with no corticosteroid or antiseizure medication use for at least 4 weeks prior
- Agree to use effective contraception or abstinence if of childbearing potential
- Agree to discontinue or postpone nursing during study therapy and for 12 months after cell product administration
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Received systemic therapy, investigational therapy, radiation, or surgery within 14 days before leukapheresis or within 21 days before lymphodepleting chemotherapy
- Prior use of anti-PD-1, anti-PD-L1 antibodies, or immune-stimulating agents within 8 weeks before treatment
- Have primary immunodeficiency disorders
- Active or history of autoimmune or immune-mediated diseases except certain endocrine deficiencies and vitiligo
- History of severe allergic reaction to cyclophosphamide or fludarabine
- Use of therapeutic systemic corticosteroids within 14 days before treatment (physiological doses allowed)
- Lung fibrosis, inflammatory lung disease, or pneumonitis on baseline imaging or history
- Other prior or concurrent malignancies except certain treated cancers in remission
- Electrocardiogram showing prolonged QTc interval beyond specified limits
- Active infections with HIV, hepatitis B or C, or HTLV
- Pregnant or intending to become pregnant during the contraception period
- Received live or attenuated vaccines within 30 days before treatment
- History of seizure disorder unless due to treated metastatic lesions
- Uncontrolled intercurrent illness that may affect safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
M
Maria Gracia L Agra, R.N.
CONTACT
R
Raffit Hassan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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