RecruitingPhase 1NCT06885697

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

Phase 1 Study With Dose Expansion of the Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma


Sponsor

National Cancer Institute (NCI)

Enrollment

100 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of CAR T-cell therapy — a treatment where your own immune cells are genetically engineered to attack cancer — called TNhYP218, which targets a protein called mesothelin found on certain solid tumors, including mesothelioma and other cancers. **You may be eligible if...** - You are 18 or older - You have unresectable, advanced, or recurrent mesothelioma (epithelioid or mostly epithelioid type) or another solid tumor that expresses mesothelin at high levels - Your cancer has progressed after at least one FDA-approved standard treatment - Your tumor tests positive for mesothelin by biopsy - Your cancer is measurable on imaging - You are in good overall health (ECOG 0 or 1) **You may NOT be eligible if...** - Your tumor does not express mesothelin - You have active autoimmune disease or are on immunosuppressive medications - You have significant heart, liver, kidney, or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEmesothelin expression testing

Assay done at screening to determine mesothelin expression levels

BIOLOGICALTNhYP217 CAR T Cells

Variable doses, administered intravenously on Day 0

DRUGfludarabine

30 mg/m\^2 IV infusion administered followed by cyclophosphamide on days both are given. Daily x 4 doses on Day -7, -6, -5 and -4

DRUGcyclophosphamide

600 mg/m\^2 IV infusion. Daily x 3 doses on Day -6, -5, -4


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06885697


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