ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-06
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06105021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Confirmed KRAS G12V mutational status and HLA-A\*11:01 allele
  2. 2. Histologically confirmed advanced or metastatic, unresectable solid tumor
  3. 3. Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy.
  4. 4. Measurable disease per RECIST v1.1.
  5. 5. ECOG performance status 0-1
  6. 6. Adequate organ and bone marrow function
  1. 1. Any systemic cytotoxic chemotherapy, investigational agents, or any anti-tumor drug from a previous treatment regimen or clinical study (including small molecules and I/O compounds) within 5 half-lives or 14 days of Screening, whichever is shorter.
  2. 2. Any prior gene therapy utilizing an integrating vector
  3. 3. Previous allogeneic stem cell transplantation or prior organ transplantation
  4. 4. History of treated primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease
  5. 5. Primary brain tumor
  6. 6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
  7. 7. Uncontrolled active bacterial, viral, fungal, or mycobacterial infection
  8. 8. Pregnant or lactating subjects
  9. 9. Surgery or catheter-based interventions
  10. 10. Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with lymphodepleting chemotherapy (LDC) or AFNT-211 product
  11. 11. Uncontrolled significant intercurrent or recent illness
  12. 12. Diagnosis of another malignancy within 2 years prior to screening.
  13. 13. Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb)
  14. 14. Seropositive for hepatitis C antibody.
  15. 15. Known human immunodeficiency virus (HIV) infection

Contacts and Locations

Study Locations (Sites)

USC Norris Comprehensive
Los Angeles, California, 90033
United States
University of California Los Angeles Department of Medicine
Los Angeles, California, 90095
United States
Yale New Haven Hospital
New Haven, Connecticut, 06511
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Affini-T Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-06
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-03-06
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • PDAC
  • NSCLC
  • CRC
  • human leukocyte antigen-A
  • Kirsten rat sarcoma
  • HLA-A*11:01
  • KRAS
  • G12V
  • LDC
  • Lymphodepleting chemotherapy

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Solid Tumor
  • KRAS G12V