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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

NCT07145450 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

ANOC-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.

BIOLOGICAL

ANOC-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.

BIOLOGICAL

ANOC-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

Sponsors & Collaborators

  • Anocca AB

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2030-04-02
Completion
2030-07-31

Countries

  • Denmark
  • Germany
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145450 on ClinicalTrials.gov