OncoMatch/Clinical Trials/NCT05908643
A First-In-Human Trial of pTTL in Advanced Colorectal Cancer
Is NCT05908643 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05908643 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages