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MinorEnrollment increased: 100 → 120 participantsSecondary endpoints: details revised at 2 of 8 entries · Study description expanded, about 16 words · Eligibility criteria expanded, about 3 wordsShow 3 more changesShow less
Secondary endpoints: details revised at 2 of 8 entries
Study description expanded, about 16 words
Eligibility criteria expanded, about 3 words
MinorInterventions: TNhYP217 CAR T Cells (Biological), cyclophosphamide (Drug), fludarabine (Drug), mesothelin expression testing (Device) to TNhYP218 CAR T Cells (Biological), cyclophosphamide (Drug), fludarabine (Drug), mesothelin expression testing (Device)v46
Minor11 versionsRe-verified since Aug 29, 2025, no change to tracked fieldsv35-v45
MinorStart date changed from estimate of Jul 15, 2025 to Jul 8, 2025v33
MinorStart date: Jul 14, 2025 to Jul 15, 2025v32
MinorStart date: Jul 13, 2025 to Jul 14, 2025v31
MinorStart date: Jul 9, 2025 to Jul 13, 2025v30
MinorStart date: Jul 8, 2025 to Jul 9, 2025v29
MinorStart date: Jul 7, 2025 to Jul 8, 2025v28
MinorStart date: Jul 6, 2025 to Jul 7, 2025v27
MinorStart date: Jul 3, 2025 to Jul 6, 2025v26
MinorStart date: Jul 2, 2025 to Jul 3, 2025v25
MinorStart date: Jul 1, 2025 to Jul 2, 2025v24
MinorStart date: Jun 30, 2025 to Jul 1, 2025v23
MinorStart date: Jun 29, 2025 to Jun 30, 2025v22
MinorStart date: Jun 26, 2025 to Jun 29, 2025v21
MinorStart date: Jun 24, 2025 to Jun 26, 2025v20
NotableTrial status: Not Yet Recruiting to RecruitingStart date: Jun 23, 2025 to Jun 24, 2025 · Site details revisedv19Show 2 more changesShow less
Start date: Jun 23, 2025 to Jun 24, 2025
Site details revised
MinorStart date: Jun 20, 2025 to Jun 23, 2025v18
MinorStart date: Jun 19, 2025 to Jun 20, 2025v17
MinorStart date: Jun 18, 2025 to Jun 19, 2025v16
MinorStart date: Jun 17, 2025 to Jun 18, 2025v15
MinorStart date: Jun 16, 2025 to Jun 17, 2025v14
MinorStart date: Jun 15, 2025 to Jun 16, 2025v13
MinorStart date: Jun 12, 2025 to Jun 15, 2025v12
MinorStart date: Jun 11, 2025 to Jun 12, 2025v11
MinorStart date: Jun 10, 2025 to Jun 11, 2025v10
MinorStart date: Jun 9, 2025 to Jun 10, 2025v9
MinorStart date: Jun 8, 2025 to Jun 9, 2025v8
MinorStart date: Jun 5, 2025 to Jun 8, 2025v7
MinorStart date: Jun 3, 2025 to Jun 5, 2025v6
MinorStart date: Jun 2, 2025 to Jun 3, 2025v5
MinorStart date: Jun 1, 2025 to Jun 2, 2025v4
MinorStudy Status, Arms and Interventions, Eligibilityv3
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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....