Engineered T cells targeting KRAS mutations for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center, single-arm Phase 1/2 program uses autologous TCR‑modified T cells engineered to recognize KRAS G12V or G12D peptides presented by specific HLA alleles. Treatment involves leukapheresis to collect immune cells, ex vivo TCR modification and expansion, lymphodepletion, and infusion of the TCR‑T product with follow-up for safety, cell expansion/persistence and anti-tumor activity. Each sub-study uses a classical 3+3 dose-escalation to identify a tolerable dose, followed by Phase 2 expansion at the selected dose. The trial is enrolling adults with metastatic or locally advanced PDAC whose tumors harbor the target KRAS mutation and required HLA type.

Why it matters

Who can join: the full rules

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.

Where it's running

• Herlev and Gentofte University Hospital
  Copenhagen, Denmark Recruiting
• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
  Dresden, Germany Recruiting
• Universitaetsklinikum Heidelberg
  Heidelberg, Germany Recruiting
• University Hospital and Faculty of Medicine Eberhard Karls University Tübingen
  Tübingen, Germany Recruiting
• Amsterdam UMC - VU Medical Center
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Amu Wang
• Email: amu.wang@anocca.com
• Phone: +46703784946

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zoldonrasib plus Daraxonrasib vs Gemcitabine and Nab-Paclitaxel as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This study tests whether two investigational RAS inhibitors together can improve outcomes compared with standard chemotherapy in adults with newly diagnosed metastatic pancreatic cancer carrying the KRAS G12D mutation.

  Recruiting at 6 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 5 other locations · NCT07805954

• Zoldonrasib + chemotherapy vs placebo + chemotherapy as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This trial tests whether adding zoldonrasib to standard chemotherapy helps people with newly diagnosed metastatic KRAS G12D pancreatic cancer.

  Recruiting at 25 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 24 other locations · NCT07621718

• Atebimetinib plus gemcitabine and nab‑paclitaxel as first‑line treatment for metastatic pancreatic cancer

  This trial will test whether adding the MAPK pathway drug atebimetinib to gemcitabine and nab‑paclitaxel helps people with newly diagnosed metastatic pancreatic ductal adenocarcinoma live longer.

  Recruiting at 76 sites Phase 3 Immuneering Corporation · Huntsville, Alabama and 75 other locations · NCT07562152

• Daraxonrasib alone or with gemcitabine and nab-paclitaxel for first-line metastatic pancreatic cancer

  This trial will see if daraxonrasib, alone or with gemcitabine and nab-paclitaxel, helps people with newly diagnosed metastatic pancreatic cancer live longer or slow tumor growth compared with standard gemcitabine and nab-paclitaxel.

  Recruiting at 61 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 81 other locations · NCT07491445

• Telisotuzumab adizutecan with FOLFOX versus standard care in first-line metastatic pancreatic cancer

  This study tests whether adding telisotuzumab adizutecan to FOLFOX helps adults with unresectable, metastatic pancreatic cancer compare to standard treatment.

  Recruiting at 22 sites Phase 2/3 AbbVie · New Haven, Connecticut and 21 other locations · NCT07490301

• IN10018 plus RNK08954 for KRASG12D-positive advanced solid tumors

  This trial will test whether combining IN10018 with RNK08954 can shrink tumors or control disease in people with KRASG12D-mutated locally advanced or metastatic solid tumors, with enrollment focused on pancreatic cancer.

  Recruiting Phase 1/2 InxMed (Shanghai) Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07441174

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.