Status:
RECRUITING
Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC
Lead Sponsor:
Anocca AB
Conditions:
PDAC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
This is a phase 1/2 study of engineered autologous T cells (TCR targeting KRAS G12V (ANOC-001 sub-study 1), (ANOC-002 sub-study 2) and KRAS 12D (ANOC-003 sub-study 3) capable of recognizing the tumour...
Eligibility Criteria
Inclusion
- Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.
- HLA genotyping confirmed with a high-resolution method.
- Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.
- Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC).
- Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement.
- Measurable disease by RECIST 1.1 criteria at the time of first treatment. Baseline imaging (for example, diagnostic CT chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), magnetic resonance imaging (MRI or CT scan) must be obtained within 8 weeks of the first planned T cell infusion. CT can be substituted for MRI in patients unable to have CT contrast.
Exclusion
- Another malignancy other than PDAC.
- Current or history of brain metastasis.
- Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
Key Trial Info
Start Date :
July 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT07145450
Start Date
July 3 2025
End Date
July 31 2030
Last Update
August 28 2025
Active Locations (8)
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1
Herlev and Gentofte University Hospital
Copenhagen, Denmark
2
Charité Universitätsmedizin Berlin
Berlin, Germany
3
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
4
Universitaetsklinikum Heidelberg
Heidelberg, Germany