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

NCT06885697 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Mesothelioma
  • Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Ovarian Neoplasms
  • Lung Neoplasms
  • Thymus Neoplasms
  • Colonic Neoplasms

Interventions

DEVICE

mesothelin expression testing

Assay done at screening to determine mesothelin expression levels

BIOLOGICAL

TNhYP217 CAR T Cells

Variable doses, administered intravenously on Day 0

DRUG

fludarabine

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

DRUG

cyclophosphamide

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Raffit Hassan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2034-06-01
Completion
2044-06-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06885697 on ClinicalTrials.gov