The purpose of this study is to evaluate the safety and efficacy of ascending doses of 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 a open-label, dose estilation study to evaluate the safety and anti-tumor efficacy of 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.
First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
First Affliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Dose Limiting Toxicities (DLTs) occurence
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 35 days after T cell infusion
Objective Response Rate
The total response rate after 90 days of treatment with study drug (overall response rate for ALL= CR+CRi; for NHL=CR+PR);
Time frame: At 12 weeks, and overall
Day 90 progression-free survival
The 90-day progression-free survival rate following drug therapy.
Time frame: Assessed up to 3 months
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