Three sequential dose cohorts are predefined for single administration: Cohort 1 (1.0 × 10⁶ cells/kg), Cohort 2 (2.0 × 10⁶ cells/kg), and Cohort 3 (4.0 × 10⁶ cells/kg). Escalation proceeds from Cohort 1 to Cohort 3 according to a "3 + 3" algorithm, with each subject receiving a single assigned dose. To ensure maximal subject safety, the first subject in every cohort must complete ≥ 14 days of post-dose observation within the DLT evaluation window before additional subjects in that cohort may be dosed. After the last subject in a cohort has completed the entire DLT observation period (from dosing through Day 29), the Safety Review Committee (SRC) will review the cumulative safety data and, by consensus, determine whether escalation to the first subject of the subsequent cohort may commence. Concurrent enrollment into two or more cohorts is prohibited. Upon completion of the Week 12 assessment in the last subject enrolled in Phase I, one or two dose levels will be selected for Phase II expansion based on the safety and preliminary efficacy data obtained during Phase I.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Dose-limiting toxicity (DLT).
Timeframe: Within 29 days after administration
Types and incidence of treatment-related adverse events during the DLT observation period.
Timeframe: Within 29 days after administration