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Clinical Trial Summary

Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.


Clinical Trial Description

This is an open-label, single arm study on up to 24 adult subjects with refractory or relapsed CD19+ Non-Hodgkin's Lymphoma or B-ALL. Following lymphodepleting conditioning regimen, the patients will receive a single dose of autologous CAR19 T lymphocytes provided by the sponsor´s manufacturing facility. CART19 dose will be escalated in consecutive patients using accelerated titration design in order to establish recommended CART19 dose for further study, which will be either Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD), whichever is reached first. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05054257
Study type Interventional
Source Institute of Hematology and Blood Transfusion, Czech Republic
Contact Jan Vydra
Phone +420221977182
Email jan.vydra@uhk.cz
Status Recruiting
Phase Phase 1
Start date June 2, 2021
Completion date June 1, 2025

See also
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