Pancreatic Cancer Research

Clinical trialPhase 1Unknown

CAR-macrophages for the Treatment of 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

Outcome
Outcome unknown
Phase
Phase 1
Status
Unknown
Study type
Interventional
Start
2 February 2021
Expected end
31 December 2024
Enrollment
48 participants
Sites
7
Primary outcomes
Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.; Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria.; 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)
Sponsor
Industry
Results posted
No
Last update
18 December 2024

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Brief summary public domain (ClinicalTrials.gov)

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

Detailed description public domain (ClinicalTrials.gov)

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