CD5 CAR-NK Cells for Refractory Invasive Mold Disease

The primary objective of this study is to evaluate the use of CD5CAR-NK cells in patients diagnosed with refractory invasive mold disease. This investigation is clinically relevant for addressing therapeutic resistance in fungal infections that do not respond to standard antifungal regimens. No secondary objectives are specified.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with refractory invasive mold disease. The cohort includes both male and female individuals. Participants are categorized within the vulnerable population. The age range for the subjects corresponds to age groups 3 and 4.

This Phase 1 clinical trial is designed to evaluate the safety and efficacy of CD5CAR-NK cells in patients diagnosed with refractory invasive mold disease. The study follows a controlled methodology to assess the therapeutic potential of the investigated cellular product. The clinical sequence begins with a screening visit to determine eligibility based on predefined criteria. Following successful enrollment, participants will undergo a series of follow-up visits to monitor clinical responses and safety profiles. The protocol concludes with an end-of-study visit to finalize data collection. The total duration of study activities is estimated to span three years, from May 2026 to May 2029. Individual involvement may be subject to early termination if specific clinical or safety criteria are met.

The assessment of efficacy in this study pertains to the management of refractory invasive mold disease. Due to the nature of the Phase 1 clinical trial, specific parameters for evaluating therapeutic effectiveness have not been defined.