drugset / Trial / NCT02761915
A Phase I Trial of Anti-GD2 T-cells (1RG-CART)
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this first in human study is to determine the safety and feasibility of 1RG-CART therapy in patients with relapsed or refractory neuroblastoma. 1RG-CART therapy is a novel immunotherapy under investigation in which patients have their T-cells (a type of white blood cell) collected and modified in the laboratory, before they are given back to the patient. The T-cells are modified to express a chimeric antigen receptor (CAR) which targets disialoganglioside (GD2), a marker expressed on the surface of neuroblastoma cells.
Timeline
- Start
- 2016-02-29
- Primary completion
- 2020-12-16
- Completion
- 2020-12-16
Publications
- Background Straathof K, Flutter B, Wallace R, Jain N, Loka T, Depani S, Wright G, Thomas S, Cheung GW, Gileadi T, Stafford S, Kokalaki E, Barton J, Marriott C, Rampling D, Ogunbiyi O, Akarca AU, Marafioti T, Inglott S, Gilmour K, Al-Hajj M, Day W, McHugh K, Biassoni L, Sizer N, Barton C, Edwards D, Dragoni I, Silvester J, Dyer K, Traub S, Elson L, Brook S, Westwood N, Robson L, Bedi A, Howe K, Barry A, Duncan C, Barone G, Pule M, Anderson J. Antitumor activity without on-target off-tumor toxicity of GD2-chimeric antigen receptor T cells in patients with neuroblastoma. Sci Transl Med. 2020 Nov 25;12(571):eabd6169. doi: 10.1126/scitranslmed.abd6169.
- Li X, Li W, Xu L, Song Y. Chimeric antigen receptor-immune cells against solid tumors: Structures, mechanisms, recent advances, and future developments. Chin Med J (Engl). 2024 Jun 5;137(11):1285-1302. doi: 10.1097/CM9.0000000000002818. Epub 2023 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 1RG-CART | Cell therapy | 1e+07 unknown | Intravenous |
| Subject | 1RG-CART | Cell therapy | 1e+08 unknown | Intravenous |
| Subject | 1RG-CART | Cell therapy | 5e+08 unknown | Intravenous |
| Subject | 1RG-CART | Cell therapy | 1e+09 unknown | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | — |
Indications
No indication recorded.