Clinical trialPhase 1Unknown

Anti-mesothelin CAR T Cells for Patients With Recurrent or Metastatic Malignant Tumors

A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting Mesothelin in Patients With Recurred or Metastatic Malignant Tumors

NCT02930993 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Outcome unknown
Cell product: CAR-T cellsAnti-mesothelin CAR T Cells for Patients With Recurrent or Metastatic Malignant Tumors
Target antigen: mesothelinAnti-mesothelin CAR T Cells for Patients With Recurrent or Metastatic Malignant Tumors
Cell source: AutologousA Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting Mesothelin in Patients With Recurred or Metastatic Malignant Tumors
Lymphodepletion: Stated1 to 4 days after lymphodepletion, patients are intravenously infused with anti-mesothelin CAR T cells in a three-day split-dose regimen (day0,10%;
Phase: Phase 1
Status: Unknown
Study type: Interventional
Start: August 2016
Listed end: August 2019
Enrollment: 20 participants
Sites: 1
Primary outcomes: safety of infusion of autologous anti-mesothelin CAR T cells as assessed by the incidents of treatment related adverse events per NCI CTCAE V4.0
Sponsor type: Academic / other
Results posted: No
Last update: 12 October 2016

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Brief summary public domain (ClinicalTrials.gov)

This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or metastatic malignant tumors.

Intervention public domain (ClinicalTrials.gov)

Biological: anti-mesothelin CAR T cells. Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, patients are intravenously infused with anti-mesothelin CAR T cells in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).

Arm public domain (ClinicalTrials.gov)

anti-mesothelin CAR T cells (experimental): Dose escalation study aimed to assess the safety and efficacy of anti-mesothelin CAR T cells. CAR T dosage ranging from 5×10^4 /kg to 1×10^7 /kg will be tested .