A Phase I First-in-Human Dose Escalation Study to Evaluate the Safety and Efficacy of ARI-HER2 (HER2BBz CAR-T Cells) in Patients with HER2-Positive Advanced Breast Cancer

The primary objective of this Phase I first-in-human study is to evaluate the safety and efficacy of ARI-HER2, consisting of HER2BBz CAR-T cells, in patients diagnosed with advanced breast cancer characterized by HER2 positivity. This investigation is clinically significant for determining the initial tolerability and therapeutic potential of this cellular immunotherapy in a specific oncological population.

The sponsor did not provide information regarding the total number of participants. The study population consists of individuals diagnosed with HER2-positive advanced breast cancer. The participants include both females and males. Based on the age range code provided, the cohort belongs to a specific age category. The population is identified as patients and is classified as a vulnerable group.

This Phase I, first-in-human, dose escalation trial is designed to evaluate the safety and efficacy of ARI-HER2 (HER2BBz CAR-T cells) in individuals diagnosed with HER2-positive advanced breast cancer. The research methodology involves a sequential increase in dosage to determine tolerability and therapeutic potential. The study protocol commences with a screening visit to assess eligibility based on predefined criteria. Following successful screening, participants undergo the experimental intervention and subsequent follow-up visits to monitor clinical responses and adverse events. The sequence concludes with an end-of-study visit. Total participant involvement is determined by the individual's clinical progression and response to the treatment. Early termination from the study may occur due to safety concerns or specific clinical conditions as outlined in the protocol.

Efficacy assessment in this clinical trial for patients with HER2-positive advanced breast cancer is not specified.