Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07145450

Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC

Led by Anocca AB · Updated on 2025-08-28

96

Participants Needed

8

Research Sites

264 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label, multi-centre, single-arm Phase 1/2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in patients with metastatic or locally advanced PDAC.

CONDITIONS

Official Title

Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient (18 years or older) with newly diagnosed metastatic or locally advanced PDAC.
  • Confirmed HLA genotype by high-resolution testing.
  • Tumor biopsy confirming KRAS G12V or KRAS G12D mutation.
  • Fertile males and females must use effective contraception before, during, and for 6 months after last TCR infusion.
  • Clinical benefit from standard treatments with no disease progression as judged by the investigator.
  • Measurable disease by RECIST 1.1 with baseline imaging within 8 weeks prior to first T cell infusion.
Not Eligible

You will not qualify if you...

  • Presence of any malignancy other than PDAC.
  • Current or past brain metastases.
  • Known genetic status for which other treatments are available (e.g., BRCA mutation, MSI-H).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Herlev and Gentofte University Hospital

Copenhagen, Denmark

Active, Not Recruiting

2

Charité Universitätsmedizin Berlin

Berlin, Germany

Active, Not Recruiting

3

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus

Dresden, Germany

Actively Recruiting

4

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Active, Not Recruiting

5

University Hospital and Faculty of Medicine Eberhard Karls University Tübingen

Tübingen, Germany

Active, Not Recruiting

6

Amsterdam UMC - VU Medical Center

Amsterdam, Netherlands

Active, Not Recruiting

7

Radboud University Medical Center

Nijmegen, Netherlands

Active, Not Recruiting

8

Karolinska University Hospital

Stockholm, Sweden

Actively Recruiting

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Research Team

S

Sheila Forsman

CONTACT

A

Anocca AB

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC | DecenTrialz