Metastatik veya Lokal İleri PDAC'li Yetişkin Hastalarda HLA-kısıtlı KRAS Antijenini Hedefleyen TCR-modifiye T Hücre Tedavisinin Ana Protokolü

Sade dilde özet

Bu çalışma, metastatik veya lokal ileri pankreas kanseri (PDAC, pankreas duktal adenokarsinomu) olan hastalarda, tümördeki KRAS G12V veya KRAS G12D mutasyonlarını hedefleyen TCR-modifiye T hücre tedavilerini (ANOC-001, ANOC-002, ANOC-003) inceliyor. Çalışmaya, HLA genotiplemesi ve KRAS mutasyonu doğrulanmış, 18 yaş ve üzeri hastalar katılabiliyor. Çalışma Faz 1/Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Katılımcı alıyor

Sponsor

Anocca AB

Müdahale

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)

Başlangıç

03.07.2025

Tahmini bitiş

31.07.2030

Ülkeler

Denmark, Germany, Netherlands, Sweden

İlgili genler

Merkezler

• Copenhagen, Denmark
• Berlin, Germany
• Dresden, Germany
• Heidelberg, Germany
• Leipzig, Germany
• München, Germany
• Tübingen, Germany
• Amsterdam, Netherlands
• Nijmegen, Netherlands
• Stockholm, Sweden

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.