---
title: "First-in-human Phase I/IIa Trial of Personalized Tumour-Trained Lymphocytes for Advanced Colorecta"
id: "pubmed-42758681"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42758681"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42758681/"
doi: "10.1371/journal.pone.0351697"
published_at: "2026-09-18T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# First-in-human Phase I/IIa Trial of Personalized Tumour-Trained Lymphocytes for Advanced Colorecta
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42758681
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42758681/)
- **DOI:** [10.1371/journal.pone.0351697](https://doi.org/10.1371%2Fjournal.pone.0351697)
- **Published At:** 2026-09-18T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This article presents the protocol for NEOGAP-CRC-01, a first-in-human phase I/IIa trial of autologous personalized tumour-trained lymphocytes (**pTTL**) in patients with Stage IV **colorectal cancer**. - pTTL are derived from tumour-draining regional lymph nodes (RLNs) and expanded in vitro after stimulation with a tumour-selective product (TC0301) based on **EpiTCer®** micro-particles. - Tumour-specific neoantigen-forming mutations are identified by next-generation sequencing of tumour and blood, and optimal neoantigens are selected using the bioinformatics tool **PIOR®**. - Selected neoantigen epitopes are recombinantly produced, attached to paramagnetic EpiTCer® micro-particles to form TC0301, which is used to stimulate RLN-derived T cells during manufacturing. - The trial includes three parts: Part I (sequencing, RLN collection, TC0301 production and manufacturing), Part II (preconditioning with cyclophosphamide and fludarabine, single-dose pTTL infusion, and 26-week follow-up), and Part III (up to five years of follow-up). - Up to 16 patients may be enrolled. pTTL will be given as a single intravenous infusion, with the full manufactured yield administered within limits of 20 × 10^6 to 1 × 10^9 cells. - The primary endpoint is safety. Secondary endpoints include objective treatment response, overall survival, and progression-free survival. Biomarkers of pTTL persistence, product characteristics, and treatment response will be assessed. - The protocol emphasizes that pTTL target patient-specific neoantigens without genetic modification, and notes potential challenges in interpreting efficacy due to individualized products and colorectal cancer heterogeneity. - Trial authorization: EU Clinical Trial Regulation (EU No 536/2014), EU CT #2024-512296-13-00; ClinicalTrials.gov ID NCT05908643. - Conflict of interest: Several authors receive funding from or are employed by Neogap Therapeutics AB; this is declared in the source.
## Clinical Analysis & Structured Key Points
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Colorectal Cancer, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden."), [Mattias Carlsten](https://pubmed.ncbi.nlm.nih.gov/?term=Carlsten+M&cauthor_id=42758681)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#full-view-affiliation-7 "Medical Unit Cell Therapy and Allogeneic Stem cell Transplantation \(ME CAST\), Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden."), [Maximilian Kordes](https://pubmed.ncbi.nlm.nih.gov/?term=Kordes+M&cauthor_id=42758681)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#full-view-affiliation-8 "Phase I-unit, Centre for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden."), [Sofia Berglund](https://pubmed.ncbi.nlm.nih.gov/?term=Berglund+S&cauthor_id=42758681)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#full-view-affiliation-3 "Neogap Therapeutics AB, Stockholm, Sweden.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#full-view-affiliation-4 "Department of Clinical Neuroscience \(CNS\), Karolinska Institutet, Stockholm, Sweden.") Affiliations Expand ### Affiliations * 1 Department of surgical sciences, UppsalaUniversity, Sweden. * 2 Centre for clinical research Västmanland, Uppsala University, Västerås, Sweden. * 3 Neogap Therapeutics AB, Stockholm, Sweden. * 4 Department of Clinical Neuroscience (CNS), Karolinska Institutet, Stockholm, Sweden. * 5 Department of Clinical Sciences, Division of Surgery, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. * 6 Medical Unit Pelvic Cancer - Colorectal Cancer, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden. * 7 Medical Unit Cell Therapy and Allogeneic Stem cell Transplantation (ME CAST), Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden. * 8 Phase I-unit, Centre for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden. * PMID: **42758681** * DOI: [ 10.1371/journal.pone.0351697 ](https://doi.org/10.1371/journal.pone.0351697) Item in Clipboard # A first-in-human, phase I/IIa trial of the T cell immunotherapy personalised tumour trained lymphocytes in patients with advanced colorectal cancer: Study protocol Ahmed Tarfy et al. PLoS One. 2026. Show details Display options Display options Format Abstract PubMed PMID PLoS One Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22PLoS+One%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22PLoS+One%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42758681/) . 2026 Sep 18;21(9):e0351697. doi: 10.1371/journal.pone.0351697. eCollection 2026. ### Authors [Ahmed Tarfy](https://pubmed.ncbi.nlm.nih.gov/?term=Tarfy+A&cauthor_id=42758681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-1 "Department of surgical sciences, UppsalaUniversity, Sweden.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-2 "Centre for clinical research Västmanland, Uppsala University, Västerås, Sweden."), [Andrea Salmén](https://pubmed.ncbi.nlm.nih.gov/?term=Salm%C3%A9n+A&cauthor_id=42758681)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-3 "Neogap Therapeutics AB, Stockholm, Sweden."), [Guro Gafvelin](https://pubmed.ncbi.nlm.nih.gov/?term=Gafvelin+G&cauthor_id=42758681)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-3 "Neogap Therapeutics AB, Stockholm, Sweden.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-4 "Department of Clinical Neuroscience \(CNS\), Karolinska Institutet, Stockholm, Sweden."), [Hans Grönlund](https://pubmed.ncbi.nlm.nih.gov/?term=Gr%C3%B6nlund+H&cauthor_id=42758681)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-3 "Neogap Therapeutics AB, Stockholm, Sweden.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-4 "Department of Clinical Neuroscience \(CNS\), Karolinska Institutet, Stockholm, Sweden."), [Abbas Chabok](https://pubmed.ncbi.nlm.nih.gov/?term=Chabok+A&cauthor_id=42758681)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-2 "Centre for clinical research Västmanland, Uppsala University, Västerås, Sweden.")[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-5 "Department of Clinical Sciences, Division of Surgery, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden."), [Maziar Nikberg](https://pubmed.ncbi.nlm.nih.gov/?term=Nikberg+M&cauthor_id=42758681)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-1 "Department of surgical sciences, UppsalaUniversity, Sweden.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-2 "Centre for clinical research Västmanland, Uppsala University, Västerås, Sweden."), [Per J Nilsson](https://pubmed.ncbi.nlm.nih.gov/?term=Nilsson+PJ&cauthor_id=42758681)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-6 "Medical Unit Pelvic Cancer - Colorectal Cancer, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden."), [Mattias Carlsten](https://pubmed.ncbi.nlm.nih.gov/?term=Carlsten+M&cauthor_id=42758681)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-7 "Medical Unit Cell Therapy and Allogeneic Stem cell Transplantation \(ME CAST\), Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden."), [Maximilian Kordes](https://pubmed.ncbi.nlm.nih.gov/?term=Kordes+M&cauthor_id=42758681)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-8 "Phase I-unit, Centre for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden."), [Sofia Berglund](https://pubmed.ncbi.nlm.nih.gov/?term=Berglund+S&cauthor_id=42758681)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-3 "Neogap Therapeutics AB, Stockholm, Sweden.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42758681/#short-view-affiliation-4 "Department of Clinical Neuroscience \(CNS\), Karolinska Institutet, Stockholm, Sweden.") ### Affiliations * 1 Department of surgical sciences, UppsalaUniversity, Sweden. * 2 Centre for clinical research Västmanland, Uppsala University, Västerås, Sweden. * 3 Neogap Therapeutics AB, Stockholm, Sweden. * 4 Department of Clinical Neuroscience (CNS), Karolinska Institutet, Stockholm, Sweden. * 5 Department of Clinical Sciences, Division of Surgery, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden. * 6 Medical Unit Pelvic Cancer - Colorectal Cancer, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden. * 7 Medical Unit Cell Therapy and Allogeneic Stem cell Transplantation (ME CAST), Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden. * 8 Phase I-unit, Centre for Clinical Cancer Studies, Karolinska Comprehensive Cancer Center, Karolinska University Hospital, Stockholm, Sweden. * PMID: **42758681** * DOI: [ 10.1371/journal.pone.0351697 ](https://doi.org/10.1371/journal.pone.0351697) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Adoptive T cell therapy is a promising alternative to conventional therapies for certain solid tumours. Personalized tumour-trained lymphocytes (pTTL) is an autologous T cell therapy derived from tumour-draining regional lymph nodes (RLNs), trained to target patient-specific neoantigens arising from tumour-specific mutations. The protocol for an ongoing phase I/IIa first-in-human trial of pTTL in Stage IV Colorectal Cancer (CRC), NEOGAP-CRC-01, is presented here. **Methods:** pTTL is produced by in vitro expansion of T cells from RLNs using EpiTCer® technology. Tumour-specific neoantigen-forming mutations are identified through next-generation sequencing of tumour and blood samples and the most optimal neoantigens are selected using the bioinformatics software PIOR®. Selected neoantigen epitopes are included in recombinantly produced proteins and attached to paramagnetic EpiTCer® micro-particles, forming the tumour-selective T cell stimulus TC0301 used in pTTL manufacturing. The trial comprises three parts: Part I includes sequencing of tumour and blood samples, RLNs collection, TC0301 production and pTTL manufacturing. Part II includes preconditioning, pTTL administration and 26 weeks follow-up, and Part III consists of up to five years follow-up after pTTL administration. Up to 16 patients can be included. pTTL is administered as a single-dose infusion following preconditioning with cyclophosphamide and fludarabine. Between the limits of 20 x 106-1 x 109 cells, the entire pTTL yield will be administered. **Discussion:** pTTL represents a novel approach within adoptive T-cell therapy, using autologous T cells trained to target selected neoantigens without genetic modification. The integration of PIOR® and EpiTCer® technology enables individualized neoantigen identification and delivery. Interpretation of treatment efficacy may be challenging due to the highly personalized nature of pTTL and the heterogeneity of CRC. The primary trial endpoint is safety. Secondary endpoints include objective treatment response, overall survival, and progression-free survival. Biomarkers of pTTL persistence, product characteristics, and treatment response will be assessed. **Trial registration:** Authorized under the Clinical Trial Regulation (Regulation EU No 536/2014), EU CT #2024-512296-13-00. ClinicalTrials.gov ID [NCT05908643](http://clinicaltrials.gov/show/NCT05908643 "See in ClinicalTrials.gov"). Copyright: © 2026 Tarfy et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement AT, MN, and AC receive research funding from Neogap Therapeutics AB for the development of pTTL. SB, AS, GG, and HG are employed by, and receive salaries from, Neogap Therapeutics AB. The declared competing interests do not alter our adherence to PLOS ONE policies on sharing data and materials. ## Publication types * Clinical Trial Protocol Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Clinical+Trial+Protocol%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Clinical+Trial+Protocol) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42758681/) ## MeSH terms * Antigens, Neoplasm / genetics Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Antigens%2C+Neoplasm%2Fgenetics%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Antigens%2C+Neoplasm) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42758681/) * Antigens, Neoplasm / immunology Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Antigens%2C+Neoplasm%2Fimmunology%22%5BMeSH%5D&sort=date&
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