RecruitingPhase 1interventionalRules rewrite

Phase 1: testing cyclophosphamide for 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.

Official registry: https://clinicaltrials.gov/study/NCT06885697 · National Cancer Institute (NCI) · enrollment listed as 120

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are cyclophosphamide, fludarabine, or TNhYP218 CAR T Cells. The registry lists allocation as randomized. 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.

They plan to enroll about 120 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: cyclophosphamide, fludarabine, TNhYP218 CAR T Cells, mesothelin expression testing

Primary outcome (registry wording): Establish the recommended phase 2 dose (RP2D) of TNhYP218 CAR T cells based on dose-limiting toxicity (DLT) of defined adverse events (AEs).

Who it is for (from inclusion criteria)

Ages 18 Years to 120 Years
In order to be eligible to participate in this study, an individual must meet all of the following criteria. For this protocol, treatment initiation is defined as the first day of lymphodepleting chemotherapy
Participant must have at least 1 measurable lesion by RECIST version 1.1
Tumor must have MSLN positivity of 2+ to 3+ in \>= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants must have adequate organ and marrow function as defined below:
System: Laboratory Value
Hemoglobin: \>=9 g/dL(a)

Who the registry excludes

An individual who meets any of the following criteria will be excluded from participation in this study:
Prior systemic therapy, an investigational therapy, radiation, and/or surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy
Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation
Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency)
History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine
Therapeutic doses of systemic corticosteroid therapy within 14 days prior to treatment initiation. Physiological doses of steroids (up to 5mg/day of prednisolone or equivalent) are allowed. Corticosteroid creams, ointments, and eye drops are allowed
Participants with lung fibrosis, inflammatory lung disease or evidence of pneumonitis on baseline imaging studies or medical history of these disorders

Public study contact (from the registry)

Cathy I Wagner, R.N.

(240) 858-3159

cathy.wagner@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Evaluation for NCI Surgery Branch Clinical Research Protocols

Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.

NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Collection of Blood From Patients With Cancer

This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.

NCT00034216 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phasePittsburgh, Pennsylvania

Not a traditional drug phase: Biopsy of the major carinal area for Lung Cancer

The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.

NCT00280202 · Official ClinicalTrials.gov record · University of Pittsburgh

FAQ about this NCT record

Is NCT06885697 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06885697?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06885697?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary