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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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAnocca AB
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease. 2. HLA genotyping confirmed with a high-resolution method. 3. Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample. 4. 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). 5. Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement. 6. Measurable disease by RECIST 1.1 criteria at the time of first treatment. Baseline imaging (for example, diagnostic CT of chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), or magnetic resonance imaging (MRI) 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 Criteria: 1. Another malignancy other than PDAC. 2. Current or history of brain metastasis. 3. Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
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What it tests

  • ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)
  • ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)
  • ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)
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Where

10 sites
Herlev and Gentofte University Hospital
Copenhagen, Denmark
Charité Universitätsmedizin Berlin
Berlin, Germany
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Leipzig - Universitaeren Krebszentrum (UCCL)
Leipzig, Germany
Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen - Campus Grosshadern - Medizinische Klinik und Poliklinik III
München, Germany
University Hospital and Faculty of Medicine Eberhard Karls University Tübingen
Tübingen, Germany
Amsterdam UMC - VU Medical Center
Amsterdam, Netherlands

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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