Actively Recruiting
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
Eligibility Criteria
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.
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
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
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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