Condition: Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma · Sponsor: The First Affiliated Hospital of Soochow University
Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL). Additionally, the study seeks to preliminarily assess the efficacy of CXCR4 CCR9 CAR-T cells and explore the appropriate dosage and administration schedule for subsequent Phase II clinical trials. A dose escalation study following the 3+3 design was implemented across three dose cohorts, with each cohort planned to enroll 3 to 6 patients, totaling 9 to 18 participants. Following cell infusion, subjects underwent safety and efficacy follow-up, which continued until 2 years post-infusion, subject withdrawal, or study termination-whichever occurred first. For subjects with available follow-up information after study completion or early termination, long-term follow-up-including long-term safety monitoring-was conducted for up to 15 years.
This description comes directly from the study's public registry record.
Sheng-Li Xue, M.D. · 008651267781139 · slxue@suda.edu.cn
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| The First Affiliated Hospital of Soochow University | Suzhou, Jiangsu, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07350863