A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod CAR T, in Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

What this Trial Is About

Researchers are evaluating A2B395, an allogeneic logic-gated Tmod CAR T-cell therapy, in adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express EGFR and have lost HLA-A*02 expression. This includes colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, renal cell carcinoma, and other solid tumors. The study aims to determine the safe dose and effectiveness of A2B395 in targeting tumor cells while protecting healthy cells. The study is a seamless phase 1/2, multi-center, open-label trial where participants first undergo a preconditioning lymphodepletion regimen. They then receive a single intravenous dose of A2B395 on day 0. Participants must be enrolled in a prior related study confirming loss of heterozygosity of HLA-A*02 by sequencing. The study consists of two phases: phase 1 to find the recommended dose and phase 2 to assess the treatment's safety and tumor response. Participants will be closely monitored through scheduled assessments for up to 24 months after receiving A2B395. Researchers will track adverse events, dose-limiting toxicities, overall response rate, persistence of the therapy, and cytokine levels. The study includes long-term safety follow-up and requires participants to comply with all study procedures and assessments during this period, which may last up to two years after treatment.

A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression