A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases
This is a single arm, open-label, single-center study. This study is indicated for CD 70 CAR T for patients with CD70 positive malignant hematologic diseases. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 108 patients will be enrolled. Primary objective is to explore the safety,main consideration is dose-related safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Each subject receive CD70 CAR T-cells by intravenous infusion
The first affiliated hospital of medical college of 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 CD70 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 CD70 targeted CAR T-cells infusion
Acute Myeloid Leukemia (AML), Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24
Time frame: At Month 1, 3, 6, 12, 18 and 24
AML, Overall survival (OS)
From the first infusion of CD70 CAR-T cells to death or the last visit
Time frame: Up to 2 years after CD70 CAR-T cells infusion
AML, Event-free survival (EFS)
From the first infusion of CD70 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 CD70 CAR-T cells infusion
Non-Hodgkin's lymphoma (NHL), Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24
Time frame: At Month 1, 3, 6, 12, 18 and 24
NHL, Overall survival (OS)
From the first infusion of CD70 CAR-T cells to death or the last visit
Time frame: Up to 2 years after CD70 CAR-T cells infusion
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NHL, Event-free survival (EFS)
From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse,
Time frame: Up to 2 years after CD70 CAR-T cells infusion
Multiple myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi) 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 CD70 CAR-T cells to death or the last visit
Time frame: Up to 2 years after CD70 CAR-T cells infusion
MM, Event-free survival (EFS)
From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse
Time frame: Up to 2 years after CD70 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