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A First-In-Human Trial of pTTL in Advanced Colorectal Cancer

NCT05908643 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

pTTL

pTTL is an autologous cell product for adoptive cancer immunotherapy containing in vitro expanded T cells stimulated with patient-specific tumour neoantigens derived from tumour-draining lymph nodes.

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Karolinska University Hospital

    collaborator OTHER

  • Region Västmanland

    collaborator OTHER

  • Vecura

    collaborator UNKNOWN

  • Neogap Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Maximilian Kordes, MD, PhD · Medical Unit Cell therapy and Allogeneic Stem cell Transplantation, Karolinska University Hospital

  • Abbas Chabok, MD, PhD · Unit for Colorectal Surgery, Dept. of Surgery, Västmanlands Sjukhus Västerås

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2027-12-31
Completion
2032-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908643 on ClinicalTrials.gov