This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed/refractory B-cell hematologic malignancies. 12 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The secondary objective is to evaluate the efficacy of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The exploratory objective is to evaluate expansion, persistence and ability of 19UCART to deplete CD19 positive cells in patients with relapsed/refractory B-cell hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
19UCART injection is a CD19-targeted allogenic CAR-T. A single infusion of CAR-T cells will be administered intravenously.
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Toxicity and adverse-event grading after 19UCART treatment
all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0
Time frame: up to 12 months after infusion
CRS grading after 19UCART treatment
CRS will be graded using the Lee DW et al. CRS grading scale
Time frame: up to 12 months after infusion
Overall response rate (ORR = CR + PR) of patients receive 19UCART treatment
according to the Lugano criteria and CSCO guidelines
Time frame: 1, 3, 6, and 12 months after infusion
Disease control rate (DCR = CR + PR + SD) of patients receive 19UCART treatment
according to the Lugano criteria and CSCO guidelines
Time frame: 1, 3, 6, and 12 months after infusion
PET-CT Response Criteria according to Lugano metabolic response categories
Tumor measurements and evaluations must be performed with the same technique used at baseline. CMR (5-PS 1-3 in all baseline sites); PMR (5-PS 4-5 but uptake ↓ vs base or ΔSUVmax ↓ ≥ 25 %); NMR (5-PS 4-5 with no significant Δ); PMD (5-PS 4-5 and uptake ↑ \> 50 % or new lesion). Deauville 5-Point Scale (5-PS): Scores 1-3 = metabolic CR; 4-5 = residual disease.
Time frame: 1, 3, 6, and 12 months after infusion
CAR copies and cell count of CAR-T in blood after 19UCART treatment
Time frame: Day 0, 1, 3, 5, 7, 9, 11, 14, 21, 28, and month 2, 3, 6, 9, 12 after infusion
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