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

Launched by AFFINI-T THERAPEUTICS, INC. · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AFNT-211 for patients with advanced solid tumors that have a specific genetic change known as the KRAS G12V mutation. This mutation is commonly seen in cancers such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer. To participate, patients need to have had previous treatments that didn’t work, and they must meet certain criteria, including having a specific genetic marker (HLA-A*11:01). The trial is currently looking for adult participants who have measurable cancer that has spread and who are in good overall health.

During the study, participants will receive AFNT-211, which is made from their own immune cells that are specially modified to target their cancer. Before receiving this treatment, patients will undergo a short course of chemotherapy to help prepare their body. Throughout the trial, patients will have regular visits to monitor their health and check how well the treatment is working. The main goal is to find out the safest and most effective dose of AFNT-211 to reduce tumor size. If patients are benefiting from the treatment, they may continue in the study for as long as necessary.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Confirmed KRAS G12V mutational status and HLA-A\*11:01 allele
• • 2. Histologically confirmed advanced or metastatic, unresectable solid tumor
• • 3. Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy.
• • 4. Measurable disease per RECIST v1.1.
• • 5. ECOG performance status 0-1
• • 6. Adequate organ and bone marrow function
• Key Exclusion Criteria:
• • 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. Any prior gene therapy utilizing an integrating vector
• • 3. Previous allogeneic stem cell transplantation or prior organ transplantation
• • 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. Primary brain tumor
• • 6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
• • 7. Uncontrolled active bacterial, viral, fungal, or mycobacterial infection
• • 8. Pregnant or lactating subjects
• • 9. Surgery or catheter-based interventions
• • 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. Uncontrolled significant intercurrent or recent illness
• • 12. Diagnosis of another malignancy within 2 years prior to screening.
• • 13. Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb)
• • 14. Seropositive for hepatitis C antibody.
• • 15. Known human immunodeficiency virus (HIV) infection