RecruitingPhase 1Phase 2NCT07145450

Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC

Phase 1/2 Master Protocol for Open-Label, Multi-Centre, Single-Arm Sub-Studies, First in Human Clinical Studies of TCR-T Therapy (Autologous TCR- Modified T-Cell Therapy) Targeting Mutated Kirsten Rat Sarcoma (mutKRAS) Administered in Metastatic or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Adult Patients With Specific mutKRAS and Human Leukocyte Antigen (HLA) Genotypes

Sponsor

Anocca AB

Enrollment

96 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

PDAC

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of T cell therapy (called TCR-T cell therapy) in adults with advanced or metastatic pancreatic cancer (PDAC). The therapy uses a patient's own immune cells that are genetically modified to target a cancer-specific mutation in the KRAS gene — a mutation present in most pancreatic cancers. **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with metastatic or locally advanced pancreatic cancer - Your tumor has a confirmed KRAS G12V or KRAS G12D mutation - You have had genetic testing (HLA typing) to confirm compatibility with the treatment - Your disease has shown benefit from standard treatment and is not progressing - Your cancer can be measured on scans **You may NOT be eligible if...** - You have another type of cancer besides pancreatic cancer - You have current or previous brain metastases - You have a known genetic marker (BRCA, MSI-H) for which other targeted treatments are available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)

The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy.

BIOLOGICALANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)

The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy.

BIOLOGICALANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)

The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy