This is a single-center phase 1 study to evaluate the safety and feasibility of huCART-meso cells given in combination with VCN-01 in patients with unresectable or metastatic pancreatic adenocarcinoma and serous epithelial ovarian cancer.
This is a Phase I study evaluating the safety and feasibility of lentiviral transduced huCARTmeso cells when given in combination with VCN-01. Dose Finding Phase: This study was initiated using a 3+3 dose (de)escalation design in order to explore the initial safety of these drugs when given in combination, as well as to establish the recommended expansion dose of VCN-01 in this setting. Expansion Phase: The trial was expanded to include two parallel treatment arms further exploring the dosing sequence and schedule of these two investigational products when given in combination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Intravenous administration of VCN-01
Intravenous administration of huCART-meso cells
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Type, frequency, severity, and attribution of AEs/SAEs as assessed by CTCAE v 5.0
Time frame: 2 years
Occurrence of dose-limiting toxicities.
Time frame: 2 years
Recommended expansion dose of VCN-01 administered in combination with huCART-meso cells
highest VCN-01 dose at which 0 or 1 DLT occurs in 6 DLT-evaluable subjects
Time frame: 42 days after Infusion #1 (huCART-meso cells or VCN-01 dependent on cohort assignment)
Occurrence of treatment-limiting toxicities (TLTs)
Number of subjects who either a) receive huCARTmeso cells and VCN-01 as per their arm assignment, or b) have a TLT qualifying event after receipt of either VCN-01 or huCART-meso cells.
Time frame: 28 days after Infusion #1 (huCART-meso cells or VCN-01 dependent on arm assignment)
Comparison of the safety profiles of the two treatment arms via descriptive analysis
Time frame: Up to 15 years post infusion
Proportion of subjects enrolled who receive one or both of the intended study infusions
In the Expansion Phase, the proportion of subjects in each treatment arm will be compared via descriptive analysis.
Time frame: 2 years
Overall Response Rate (ORR)
Time frame: 15 years
Best Overall Response (BOR)
Time frame: 15 years
Duration of Response (DOR)
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Time frame: 15 years
Progression Free Survival (PFS)
Time frame: 15 years
Overall Survival (OS)
Time frame: 15 years