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
Papers 3
- Builds on itCAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial. DOI 10.1038/s41591-025-03495-z↗
- Builds on itThe potential of cellular homing behavior in tumor immunotherapy: from basic discoveries to clinical applications of im… DOI 10.3389/fimmu.2024.1495978↗
- Builds on itMacrophage immunotherapy: overcoming impediments to realize promise. DOI 10.1016/j.it.2022.10.002↗