OncoMatch/Clinical Trials/NCT05908643
A First-In-Human Trial of pTTL in Advanced Colorectal Cancer
Is NCT05908643 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies pTTL for colorectal cancer.
Treatment: pTTL — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Haemoglobin ≥ 95 g/L (blood transfusion not less than 21 days prior to screening); Absolute neutrophil count ≥ 1.0 x 10^9/L; platelets ≥ 100 x 10^9/L
Kidney function
Serum creatinine ≤ ULN (if serum creatinine is between 1 and 1.5 x ULN, patients may be eligible provided that the calculated GFR is at least 35 mL/min using Cockcroft-Gault method)
Liver function
Total bilirubin < 1.5 x ULN (does not apply to patients with Gilberts Syndrome); AST and ALT ≤ 1.5 x ULN (or ≤ 5 x ULN in the presence of liver metastases); Albumin ≥24 g/L
Adequate hematopoietic, hepatic and renal function defined as: Haemoglobin ≥ 95 g/L (blood transfusion not less than 21 days prior to screening), Absolute neutrophil count ≥ 1.0 x 10^9/L, platelets ≥100 x 10^9/L, Total bilirubin < 1.5 x ULN (does not apply to patients with Gilberts Syndrome), AST and ALT ≤ 1.5 x ULN (or ≤ 5 x ULN in the presence of liver metastases), Serum creatinine ≤ ULN (if serum creatinine is between 1 and 1.5 x ULN, patients may be eligible provided that the calculated GFR is at least 35 mL/min using Cockcroft-Gault method), Albumin ≥24 g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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