A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies
This is a single arm, open-label, single-center study. This study is indicated for LMP1 positive infectious diseases and hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 144 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
144
Each subject receive LMP1 CAR T-cells by intravenous infusion
The First Affiliated Hospital,College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after LMP1 targeted 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 LMP1 targeted CAR T-cells infusion
Chronic active EB virus infection (CAEBV), Overall response rate (ORR)
Assessment of ORR (ORR = CR + PR) at Month 1, 3, 6, 12, 18 and 24
Time frame: At Month 1, 3, 6, 12, 18 and 24
CAEBV,Duration of remission(DOR)
From the first remission after LMP1 CAR-T cells to relapse, death or the last visit
Time frame: Up to 2 years after LMP1 CAR-T cells infusion
CAEBV, Overall survival (OS)
From the first infusion of LMP1 CAR-T cells to death or the last visit
Time frame: Up to 2 years after LMP1 CAR-T cells infusion
CAEBV, Relapse rate(RR)
From the first remission after LMP1 CAR-T cells to relapse or the last visit
Time frame: At Month 6, 12, 18 and 24
CAEBV, Event-free survival (EFS)
From the first infusion of LMP1 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 LMP1 CAR-T cells infusion
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Hodgkin's lymphoma(HL), Extranodal NK/T cell lymphoma(ENKTL),Nasal type, Lymphoproliferative disease after hematopoietic stem cell transplantation, (post-HSCT PTLD),Overall response rate (ORR)
Assessment of ORR (ORR = CR + PR) at Month 1, 3, 6, 12, 18 and 24
Time frame: At Month 1, 3, 6, 12, 18 and 24
HL, ENKTL, PTLD, OS
From the first infusion of LMP1 CAR-T cells to death or the last visit
Time frame: Up to 2 years after LMP1 CAR-T cells infusion
HL, ENKTL, PTLD, EFS
From the first infusion of LMP1 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 LMP3 CAR-T cells infusion
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