A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.
This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens.
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 2 years after CAR T-cells infusion
B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24
Time frame: At Month 1, 3, 6, 12, 18 and 24
B-ALL, Overall survival (OS)
From the first infusion of CAR-T cells to death or the last visit
Time frame: Up to 2 years after CAR-T cells infusion
B-ALL, Event-free survival (EFS)
From the first infusion of CAR-T cells to the occurrence of any event, including death, relapse orgene relapse, disease progression (any one occurs first), and the last visit
Time frame: Up to 2 years after CAR-T cells infusion
B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)
Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria
Time frame: At Week 4, 12, and Month 6, 12, 18, 24
B-NHL, disease control rate (DCR)
Assessment of DCR (DCR=CR+PR+SD) per Lugano 2014 criteria
Time frame: At Week 12 and Month 6, 12, 18, 24
Multiple myeloma (MM), Overall response rate (ORR)
Assessment of ORR at Day 28
Time frame: At Day 28
MM, Overall survival (OS)
Assessment of OS at Month 6, 12, 24
Time frame: At Month 6, 12, 24
Quality of life
Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
Activities of Daily Living (ADL) score
Assessment using Activities of Daily Living (ADL) scale (Barthel Index) \[max score: 100, min score: 0, higher scores mean a better outcome\] at Baseline, Month 1, 3, 6, 9 and 12
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
Instrumental Activities of Daily Living (IADL) score
Assessment of Instrumental Activities of Daily Living (IADL) scale \[max score: 56, min score: 14, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
Hospital Anxiety and Depression Scale (HADS) score
Assessment using Hospital Anxiety and Depression Scale (HADS) \[max score: 42, min score: 0, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
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