Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Malignant Pleural DiseaseMesotheliomaMetastasesLung CancerBreast Cancer
Interventions
GENETIC

iCasp9M28z T cell infusions

Administration through the pleural catheter- On day 0 patients will be treated with genetically modified T cells. Thirty to 60 minutes before T cell infusion, patients will be given 650 mg of acetaminophen orally and 25- 50 mg of diphenhydramine orally or intravenously, to prevent infusion-related reactions. The genetically modified T cells will be infused for at least 15 minutes and no more than 2 hours through the indwelling pleural catheter depending on the volume of the T cells. A physician will be available during the infusion. Please note, during formulation of iCasp9M28z T cells, under or over estimation of CAR modified T Cells may occur. Patient may receive an altered fractionation of the total dose or up to 35% over or under total cell dose with approval of the PI. Patients who do not have enough cells to match the current dose cohort will be treated in the cohort in which they have cells available

DRUG

cyclophosphamide

Patients will receive cyclophosphamide intravenously (at 1.5 g/m\^2)

DRUG

pembrolizumab

Pembrolizumab will be given as 200 mg flat dose infusion intravenously.

Trial Locations (6)

10065

Memorial Sloan Kettering Cancer Center (Consent and Follow-Up), New York

10604

Memorial Sloan Kettering Westchester (Consent and Follow-Up), Harrison

Unknown

Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up), Basking Ridge

Memorial Sloan Kettering Commack (Consent and Follow-Up), Commack

07748

Memorial Sloan Kettering Monmouth (Consent and Follow-Up), Middletown

07645

Memorial Sloan Kettering Bergen (Consent and Follow-Up), Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bellicum Pharmaceuticals

INDUSTRY

collaborator

United States Department of Defense

FED

lead

Memorial Sloan Kettering Cancer Center

OTHER