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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: Recruiting Phase 1 study of Neoplasms and Mesothelioma, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The highest dose level below the maximum administered dose at which no more than 1 of 6 participants experience DLT from the initiation of CAR-T cell infusion (day 0) through day 28 after infusion (day 28).

Conditions Studied

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

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

FieldValue
Enrollment Target 100 participants
Start Date 2025-07-08
Est. Completion 2044-06-01
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT06885697 shows while recruiting

NCT06885697 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06885697's enrollment target sits among peer trials

100 72nd of 158 higher than 87 of 158 other Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06885697

Source: ClinicalTrials.gov NCT06885697, the US trial registry maintained by the National Library of Medicine. NCT06885697 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.