Phase I Study of Personalized T Cell Therapy for Advanced or Metastatic Solid Tumors with KRAS G12V Mutation

Sponsor: Affini-T Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06105021

Provider View

This clinical trial is testing a new treatment called AFNT-211, which uses a patient's own modified T cells to target and attack cancer cells with a specific KRAS G12V mutation. The study aims to find a safe and effective dose for shrinking tumors in adults with advanced cancers that have not responded to other treatments.

Patient Parameters

Program Overview

This study is for adults with advanced solid tumors that have a specific genetic mutation known as KRAS G12V. These tumors are often found in cancers like non-small cell lung cancer, colorectal cancer, and pancreatic cancer. The trial is for patients whose cancer has spread and who have not had success with other treatments. Participants must also have a specific genetic marker called HLA-A*11:01. The goal is to find a safe dose of a new treatment called AFNT-211, which is made from the patient's own T cells. These cells are modified in the lab to recognize and attack cancer cells with the KRAS G12V mutation. Patients will receive this treatment after a short course of chemotherapy and will be monitored closely for any side effects and changes in their cancer.

Description

AFNT-211 is a new type of treatment that uses a patient's own T cells, which are a part of the immune system, to fight cancer. These T cells are taken from the patient, modified in the lab to target a specific mutation in cancer cells, and then given back to the patient. The study is being conducted to see if this treatment is safe and to find the best dose that can help shrink tumors in patients with advanced cancers that have a KRAS G12V mutation. Participants will receive the treatment after a short course of chemotherapy to prepare their body. They will have regular visits to the study site to check their health and the size of their cancer. The study will also look at how well the treatment works in reducing tumors.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed KRAS G12V mutation and the HLA-A*11:01 genetic marker.
  • Have an advanced or metastatic solid tumor that cannot be removed by surgery.
  • Have tried at least one standard treatment for their cancer that did not work or was not tolerated.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function as determined by specific medical tests.

Exclusion Criteria

  • Have received any chemotherapy or investigational drugs within a short period before the study.
  • Have had previous gene therapy or organ transplants.
  • Have a history of certain immune system diseases or primary brain tumors.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Have active infections that are not controlled.
  • Be pregnant or breastfeeding.
  • Have allergies to certain chemotherapy drugs used in the study.
  • Have other serious health conditions or another cancer diagnosed within the last two years.
  • Test positive for hepatitis B, hepatitis C, or HIV.

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