Trials / Active Not Recruiting
Active Not RecruitingNCT04660929
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Carisma Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
Detailed description
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
Conditions
- HER2-positive
- Adenocarcinoma
- Bile Duct Cancer
- Biliary Tract Cancer
- Bladder Cancer
- Breast Cancer
- Breast Neoplasm
- Carcinoma, Ductal
- Carcinoma, Hepatocellular
- Cancer
- Lung Cancer, Non-Small-Cell
- Carcinoma, Ovarian Epithelial
- Carcinoma, Small Cell
- Carcinoma, Squamous
- Carcinoma, Transitional Cell
- Colorectal Cancer
- Esophagogastric Junction Neoplasms
- Inflammatory Breast Cancer
- Stomach Neoplasms
- Malignant Neoplasms
- Ovarian Neoplasms
- Pancreatic Cancer
- HER2-positive Solid Tumors
- HER2-positive Breast Cancer
- HER2-positive Gastric Cancer
- HER-2 Protein Overexpression
- HER-2 Gene Amplification
- Prostate Cancer
- Head and Neck Cancer
- Endometrial Cancer
- Lung Cancer, Small Cell
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-0508 | anti-HER2 CAR macrophages |
| BIOLOGICAL | Pembrolizumab | anti-PD antibody |
Timeline
- Start date
- 2021-02-02
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2020-12-09
- Last updated
- 2024-12-18
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04660929. Inclusion in this directory is not an endorsement.