drugset / Trial / NCT04729543
MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer
Phase 1/2
Recruiting
20 enrolled
Erasmus Medical Center
Dutch Cancer Society · collabJan Ivo Stichting grant · collabLudwig Institute for Cancer Research · collabStichting Coolsingel Rotterdam grant · collab
NaSingle-groupOpen-labelTreatment
Summary
Single-centre, first-in-man phase I/II trial to demonstrate safety and efficacy of MAGE-C2/HLA-A2 TCR T cells (MC2 TCR T cells) in advanced melanoma (MEL) and head-and-neck carcinoma (HNSCC).
Timeline
- Start
- 2020-10-20
- Primary completion
- 2024-12-20
- Completion
- 2027-10-20
Publications
- Results Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Results Lamers CH, van Steenbergen-Langeveld S, van Brakel M, Groot-van Ruijven CM, van Elzakker PM, van Krimpen B, Sleijfer S, Debets R. T cell receptor-engineered T cells to treat solid tumors: T cell processing toward optimal T cell fitness. Hum Gene Ther Methods. 2014 Dec;25(6):345-57. doi: 10.1089/hgtb.2014.051.
- Results Kunert A, van Brakel M, van Steenbergen-Langeveld S, da Silva M, Coulie PG, Lamers C, Sleijfer S, Debets R. MAGE-C2-Specific TCRs Combined with Epigenetic Drug-Enhanced Antigenicity Yield Robust and Tumor-Selective T Cell Responses. J Immunol. 2016 Sep 15;197(6):2541-52. doi: 10.4049/jimmunol.1502024. Epub 2016 Aug 3.
- Results Kunert A, Obenaus M, Lamers CHJ, Blankenstein T, Debets R. T-cell Receptors for Clinical Therapy: In Vitro Assessment of Toxicity Risk. Clin Cancer Res. 2017 Oct 15;23(20):6012-6020. doi: 10.1158/1078-0432.CCR-17-1012. Epub 2017 Jun 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MC2 TCR T cells | Cell therapy | 5e+07 cells | Intravenous |
| Subject | MC2 TCR T cells | Cell therapy | 5e+08 cells | Intravenous |
| Subject | MC2 TCR T cells | Cell therapy | 5e+09 cells | Intravenous |
| Subject | MC2 TCR T cells | Cell therapy | 1e+10 cells | Intravenous |
| Subject | MC2 TCR T cells | Cell therapy | 5e+10 cells | Intravenous |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Background | Valproic Acid | Small molecule | 50 mg/kg | — |
| Background | aldesleukin | Protein / enzyme biologic | 500000 unknown | Subcutaneous |