This is an open-label, single-center Phase 1/2 study with a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
Tri-Service General Hospital
Taipei, Taiwan
RECRUITINGMaximum Tolerated Dose (MTD)
A standard 3+3 trial design will be used for Welgenaleucel (UWC19) dose escalation cohorts.The dosing of Welgenaleucel (UWC19) will be divided into 5 cohorts, the subjects will receive Welgenaleucel (UWC19) once on day 14-18 after apheresis.
Time frame: 30 days after infusion
Dose Limiting Toxicities (DLT)
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level.
Time frame: 30 days after infusion
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