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NCT06885697 · ClinicalTrials.gov registry record · Phase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
A Phase 1 study of Neoplasms and Mesothelioma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06885697 is a Phase 1 study of Neoplasms and Mesothelioma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 100 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06885697, a Phase 1 study of Neoplasms and Mesothelioma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG fludarabine
- DRUG cyclophosphamide
- DEVICE mesothelin expression testing
- BIOLOGICAL TNhYP217 CAR T Cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-07-08 |
| Est. Completion | 2044-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06885697
The ClinicalTrials.gov registry entry for NCT06885697 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which fludarabine is the first listed.
NCT06885697 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06885697 about?
NCT06885697 is a clinical study titled "Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma". 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 ne...
What is the current status of trial NCT06885697?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-07-08. Estimated completion is 2044-06-01.
What conditions does trial NCT06885697 study?
This clinical trial studies the following conditions: Neoplasms, Mesothelioma, Ovarian Neoplasms, Pancreatic Neoplasms, Lung Neoplasms.
What interventions are being tested in trial NCT06885697?
The interventions under investigation include: fludarabine (DRUG), cyclophosphamide (DRUG), mesothelin expression testing (DEVICE), TNhYP217 CAR T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06885697?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06885697 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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