A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Each subject receive APRIL CAR T-cells by intravenous infusion
The First Affiliated Hospital,College of Medicine, 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 APRIL targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Time Frame: Up to 2 years after APRIL targeted CAR T-cells infusion
Multiple Myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 1, 3, 6, 12, 18 and 24
Time frame: At Month 1, 3, 6, 12, 18 and 24
MM, Overall survival (OS)
From the first infusion of APRIL CAR-T cells to death or the last visit
Time frame: Up to 2 years after APRIL CAR-T cells infusion
MM, Event-free survival (EFS)
From the first infusion of APRIL CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit
Time frame: Up to 2 years after APRIL CAR-T cells infusion
Quality of life including sports activity
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
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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