The purpose of this study is to evaluate the safety and efficacy of Next-generation CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.
CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC. This is an open-label, single arm study to evaluate the safety and anti- tumor efficacy of Next-generation CD19-UCART in the treatment of relapsed or refractory B-cell hematological malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy.
Dose Limiting Toxicities (DLTs) incidence
Incidence of adverse events (AEs) defined as DLTs
Time frame: Day 0 up to 35 days after T cell infusion
Objective Response Rate (ORR)
Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed.
Time frame: At 12 weeks
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