Skip to content
DataLookout
Start free
Menu

NCT04577326

Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from Memorial Sloan Kettering Cancer Center

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 18 versions: 13 with changes below, 5 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2027
    • Eligibility criteria expanded, about 34 words
  2. Primary and study completion dates: Sep 30, 2025 to Sep 30, 2026v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 14
    • Site details revised
    v15
  4. Primary and study completion dates: Sep 30, 2024 to Sep 30, 2025v14
  5. Primary and study completion dates: Sep 2024 to Sep 30, 2024v13
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 7 to 30
    • Primary and study completion dates: Sep 2023 to Sep 2024
    • Site details revised
    v11
  2. Eligibility criteria expanded, about 19 wordsv10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 7
    • Site details revised
    v9
  4. Primary and study completion dates: Sep 2022 to Sep 2023v5
  5. Eligibility criteria expanded, about 45 wordsv4
  6. Collaborators expanded, about 2 wordsv3
  7. Study title shortened, about 1 wordv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

MTD of M28z1XXPD1DNR
Timeframe: 2 years

Secondary (1)

overall response rate (ORR)

Arms and interventions

Engineered Autologous T CellsExperimental

Following eligibility screening and enrollment, patients will undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMCs), to enable generation of M28z1XXPD1DNR. Following successful M28z1XXPD1DNR CAR T-cell manufacturing, patients will be reevaluated for eligibility. A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m2 will be administered 2-7 days before the infusion. A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. All patients will be monitored in the hospital for a minimum of 48 h following the administration of CAR T cells.

Drugs: cyclophosphamide

Biologicals: CAR T cells

Sites

1 site in 1 country

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York, United States