OncoMatch/Clinical Trials/NCT06885697
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Is NCT06885697 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including TNhYP217 CAR T Cells and mesothelin expression testing for mesothelioma.
Treatment: mesothelin expression testing · TNhYP217 CAR T Cells · fludarabine · cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Mesothelioma
Gastric Cancer
Pancreatic Cancer
Ovarian Cancer
Biomarker criteria
Required: MSLN overexpression (2+ to 3+ in >= 50% cancer cells by immunohistochemistry)
Tumor must have MSLN positivity of 2+ to 3+ in >= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: FDA-approved systemic therapy considered standard of care for their tumor type
Participant must have progressed on at least one FDA-approved systemic therapy considered standard of care for their tumor type.
Cannot have received: systemic therapy, investigational therapy, radiation, and/or surgery
Prior systemic therapy, an investigational therapy, radiation, and/or surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy.
Cannot have received: anti-PD-1 or anti-PD-L1 antibodies or other agents that can stimulate immune activity and interfere with an infusion of CAR-T cells
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.
Lab requirements
Blood counts
hemoglobin >=9 g/dL (without erythropoietin dependency and without pRBC transfusion within last 2 weeks); ANC >=1,500/mcL; platelets >=100,000/mcL
Kidney function
creatinine <=1.5x ULN OR calculated creatinine clearance (GFR can also be used) >=50 mL/min for participant with creatinine levels >1.5x ULN
Liver function
total bilirubin <=2.5x ULN OR direct bilirubin ULN for participants with total bilirubin >1.5x ULN; AST and ALT <=2.5x ULN (<=5x ULN for participants with liver metastases)
Cardiac function
Normal cardiac ejection fraction (>=45% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by echocardiogram. Electrocardiogram showing a QTc interval <=450 msec in males and <=470 msec in females (<=80 msec for participants with bundle branch block).
Participants must have adequate organ and marrow function as defined below: Hemoglobin >=9 g/dL(a); absolute neutrophil count >=1,500/mcL; platelets >=100,000/mcL; total bilirubin <=2.5 X institutional ULN OR direct bilirubin ULN for participants with total bilirubin levels >1.5 X ULN; AST and ALT <= 2.5 X institutional ULN (<= 5 X ULN for participants with liver metastases); Creatinine <=1.5 X ULN OR Calculated(b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) >= 50 mL/min for participant with creatinine levels > 1.5 X institutional ULN; Normal cardiac ejection fraction (>= 45% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06885697 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy, investigational therapy, radiation, and/or surgery, anti-PD-1 or anti-PD-L1 antibodies or other agents that can stimulate immune activity and interfere with an infusion of CAR-T cells disqualifies patients from enrollment.
Does this trial require MSLN?
Yes, MSLN overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages