Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

engineered autologous T cells

Three cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10\^7 CAR+ T cells/kg, 3 x 10\^7 CAR+ T cells/kg, and 1 x 108 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells.

DRUG

cyclophosphamide

Three cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10\^7 CAR+ T cells/kg, 3 x 10\^7 CAR+ T cells/kg, and 1 x 10\^8 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Memorial Sloan Kettering Cancer Center

OTHER