A First-In-Human Trial of pTTL in Advanced Colorectal Cancer
Summary
This is an open-label, non-randomised FIH trial investigating the safety and tolerability of a novel ATMP, pTTL, composed of autologous tumour-draining lymph node-derived T cells stimulated in vitro with personalised cancer neoantigens. The neoantigens are selected through a process starting with next generation sequencing (NGS) of tumour material from the patient followed by selection of neoantigenic mutations using an in-house software, PIOR®. Selected neoantigen epitopes are expressed as recombinant proteins, NAG, and used to stimulate T cells to promote neoantigen-specific T cell expansion in vitro in pTTL production. pTTL is thus based on autologous cells stimulated with patient-specific neoantigens. In consequence, every pTTL product is unique and designated for use in one single individual. pTTL will be administered to patients with stage IV colorectal cancer (CRC) as a single intravenous dose.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2027-12
- Completion
- 2032-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pTTL | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | pTTL | Cell therapy | 2.5e+06 cells/kg | Intravenous |
| Subject | pTTL | Cell therapy | 5e+06 cells/kg | Intravenous |
| Subject | pTTL | Cell therapy | 1e+09 cells | Intravenous |