Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects with HER2 Overexpressing Solid Tumors Main Study - Group 1 and Group 2 all HER2 overexpressing solid tumors Intraperitoneal Substudy - HER2 overexpressing peritoneal disease 89\[Zr\] radiolabeled CT-0508 Substudy - All HER2 overexpressing solid tumors (Univ of Penn, Abramson Cancer Center only) CT-0508 Combination with Pembrolizumab Substudy - All HER2 overexpressing solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
anti-HER2 CAR macrophages
anti-PD antibody
City of Hope National Medical Center
Duarte, California, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Tennessee Oncology / Sarah Cannon Research Institute
Nashville, Tennessee, United States
M D Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.
Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS)
Time frame: 14 months
Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria.
Percentage of products that pass release criteria among all manufactured products.
Time frame: 12 months
Assess the safety and tolerability of CT-0508 in combination with pembrolizumab by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors (CT-0508 and pembrolizumab substudy only)
Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS)
Time frame: 14 months
Estimate the objective response rate (ORR), according to RECIST v1.1, of at least 1 dose of CT-0508 among subjects with HER2 overexpressing solid tumors.
Proportion of subjects with an objective response (either a complete response \[CR\] or partial response \[PR\]) in subjects who received at least 1 dose of CT-0508 and at least the 8-week tumor evaluation as determined by the investigator using RECIST v1.1.
Time frame: 24 months
Estimate progression-free survival (PFS).
Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first. Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: 24 months
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