CAR T Cell Immunotherapy for Pancreatic Cancer

Summary

Participation Requirements

Description

This is a Phase I study evaluating the feasibility of producing as well as the safety of administering lentiviral transduced huCART-meso cells in up to four (4) cohorts both with and without cyclophosphamide in a three-plus-three (3+3) dose escalation design. Cohort 1(N=3-6): subjects will receive a...

This is a Phase I study evaluating the feasibility of producing as well as the safety of administering lentiviral transduced huCART-meso cells in up to four (4) cohorts both with and without cyclophosphamide in a three-plus-three (3+3) dose escalation design. Cohort 1(N=3-6): subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 without any conditioning chemotherapeutic regimen. - If one (1) Dose Limiting Toxicity (DLT) occur in three (3) subjects, the study will enroll an additional three (3) subjects at the same dose level. If zero (0) DLTs occur in three (3) subjects, or if one (1) DLT occurs in six (6) subjects, the study will begin to enroll subjects into Cohort 2. However, if two (2) DLTs occur at this dose level at any time, enrollment in Cohort 1 will be stopped, and the administered dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2, and enrollment into Cohort -1 will begin. Cohort 2 (N=3-6): subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 - If zero (0) or one (1) DLTs occur in three (3) subjects, the study will enroll an additional three (3) subjects to confirm tolerability. If two (2) DLTs occur in three (3) subjects or two (2) DLTs occur in six (6) subjects, further infusions in this cohort will be halted. Cohort 3 (N=up to 6): subjects will receive a single dose of 1-3x10^7/m2 lentiviral transduced huCART-meso cells on day 0 via intrahepatic (hepatic arterial infusion) administration. The initial intrahepatic infusion may be followed by up by two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. Cohort -1 (N=3-6): subjects will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0. Up to six (6) subjects will be infused in Cohort -1 with not more than one (1) DLT occurring in six (6) subjects to establish the Maximum Tolerated Dose (MTD). These cohorts will be used to establish the safety of this investigational product (huCART-meso cells) as well as the target dose level in the target study population. If safety is established, the study will be further amended to explore the safety of local delivery methods. Adverse events will be collected and evaluated during the protocol specified adverse event reporting period.

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