Phase I Study to Evaluate the Safety of STAb-T19 Genetically Modified T Cells Secreting αCD19xαCD3 Bispecific Antibodies in Patients with Malignant B-cell Neoplasms

The primary objective of this Phase I, first-in-human clinical trial is to evaluate the safety of administering STAb-T19 cells, which are genetically modified T lymphocytes engineered to secrete αCD19xαCD3 bispecific antibodies. This assessment is critical for determining the tolerable dose and identifying potential adverse events in patients with malignant B-cell neoplasms. 4

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with malignant B-cell neoplasms. The cohort includes both males and females. Participants belong to vulnerable populations and fall within age ranges 3 and 4.

This Phase I, first-in-human clinical trial is designed to evaluate the safety of infusing STAb-T19 cells in patients diagnosed with malignant B-cell neoplasms. The investigational product consists of genetically modified T lymphocytes engineered to secrete αCD19xαCD3 bispecific antibodies. The study methodology includes a screening visit to determine eligibility, followed by scheduled study visits to monitor clinical responses and safety parameters. The protocol concludes with an end-of-study visit. The overall duration of the trial is estimated to span from June 2026 to May 2028. Participation may be discontinued prior to the scheduled end of the study based on specific clinical criteria or safety requirements.

The efficacy assessment for this study involving patients with malignant B-cell neoplasms is not specified.