Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Lung Cancer	NCT ID:	NCT06105021
Trial Phases:	Phase I Phase II	Protocol IDs:	AFNT211-22-101 (primary) NCI-2024-02356
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Affini-T Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06105021

Summary

This study is open to adult patients with solid tumors who have a KRAS G12V mutation.
This mutation is often found in non-small cell lung cancer (NSCLC), colorectal cancer
(CRC), pancreatic ductal adenocarcinoma (PDAC) and other cancers. The study is for
patients whose cancer has spread through the body and for whom previous treatments were
not successful or treatment does not exist. Patients must also be positive for
HLA-A*11:01. The purpose of this study is to find the best dose of AFNT-211 that is safe
and can shrink tumors in patients. AFNT-211 is an investigational therapy and this is the
first time that AFNT-211 is being administered to patients. AFNT-211 is an autologous T
cell product which means that it is made from a patient's own T cells. These cells are
engineered and grown to recognize the KRAS G12V protein on the cell surface of cancer
cells. AFNT-211 is infused into patients after a short course of lymphodepleting
chemotherapy. Patients will frequently visit the study site. The doctors there will
regularly check the size of the cancer and the patient's health. They will also take note
of any unwanted effects. Patients may continue in this study for as long as they benefit
from the treatment.

Objectives

AFNT-211 is a cellular therapy consisting of autologous CD4+ and CD8+ T cells engineered
to express a human leukocyte antigen-A (HLA-A)*11:01-restricted Kirsten rat sarcoma
(KRAS) G12V-specific transgenic T cell receptor (TCR), the wildtype CD8a/ß coreceptor,
and a FAS-41BB switch receptor. AFNT-211 is being developed by Affini-T Therapeutics,
Inc. (hereafter, "the Sponsor") for the treatment of patients with malignant solid
tumors. The primary purpose of this study is to assess the safety and tolerability of
AFNT-211 in subjects who are HLA-A*11:01 positive with advanced or metastatic cancers
that harbor a KRAS G12V mutation, as well as determine the optimal biological dose (OBD)
and recommended Phase II dose (RP2D) of AFNT-211 in this population. This study will also
evaluate the preliminary anti-tumor activity of AFNT-211.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.