Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the study drug in relapsed / refractory CD7 Positive hematolymph system malignant tumor patients, so as to explore the clinical applicable dose of phase II. Since the activity and toxicity of cellular drugs (long-term survival drugs) do not have obvious dose dependence, and the increase of their dose may be accompanied by the increase of toxicity, rather than necessary for therapeutic effect, it is not necessarily suitable to recommend the effective dose according to the maximum tolerable dose (MTD). Therefore, this study will be based on the safety data, as well as the preliminary efficacy, efficacy and drug The end point of pharmacokinetics (ORR, the content of CD7 Positive Cells, the expansion and duration of car-t cells) were comprehensively considered to determine the recommended dose for phase II clinical trial.Main research purposes Objective to evaluate the safety and tolerability of T cell injection targeting CD7 autologous chimeric antigen receptor in the treatment of relapsed / refractory CD7 Positive hematological and lymphoid malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGDose-limiting toxicity (DLT)
Time frame: Up to 2 years
Safety results
Number of adverse events
Time frame: Up to 2 years
PK
The maximum concentration (Cmax)
Time frame: Up to 2 years
PK
the time to reach the maximum concentration (Tmax)
Time frame: Up to 2 years
PK
The area under the curve (auc0-28d ) at 28d respectively after administration
Time frame: Up to 2 years
PD
Absolute value of CD7 Positive Cells in peripheral blood at each time point
Time frame: Up to 2 years
PD
The proportion of CD7 Positive Cells in peripheral blood at each time point
Time frame: Up to 2 years
ORR
The total response rate was 3 months and 6 months
Time frame: Up to 2 years
overall survival (OS)
Time from initiation of CD7 car-t cell therapy to death (for any reason)
Time frame: Up to 2 years
Search Results Featured snippet from the web Duration of response (DOR)
The time from the first assessment of Cr or PR to the first assessment of recurrence or progression of the disease or death from any cause
Time frame: Up to 2 years
Progression-free survival (PFS)
The time from the beginning of treatment with CD7 car-t cells to the first progression of disease or death from any cause
Time frame: Up to 2 years
Immunogenicity
The positive rate of human anti car antibody at each time point
Time frame: Up to 2 years
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