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 (May 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
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)
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
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