CD7 CAR-T in the Treatment of CD7 Positive Refractory Relapsed Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. CAR-T cells are costimulatory molecules that include single-chain antibodies (scFv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif ITAM), and intracellular signaling regions. The chimeric antigen receptor of CD28 or CD137(4-1BB) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous T cells, so that the modified CAR-T cells have targeting and specificity Recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen

Official Title
-----------------
A Prospective, Open, Single-arm Clinical Study on the Efficacy and Safety of CD7 CAR-T in the Treatment of CD7-positive Refractory Relapsed Acute Leukemia

Conditions
-----------------
T-ALL

Intervention / Treatment
-----------------
* Drug: T cell injection targeting CD7 chimeric antigen receptor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 12-65 Sign informed consent Expected survival time ≥ 3 months CD7 positive refractory and relapsed acute leukemia Karnofsky score≥60 ECOG score ≤ 2 Have not received other immunotherapy within 3 months The CD7 expression rate on the surface of leukemia cells detected by flow cytometry is greater than 30% Exclusion Criteria: Uncontrolled active infection Active viral hepatitis B or C HIV test positive Congenital immunodeficiency patients Pregnant and breastfeeding patients Patients with central nervous system tumors or central nervous system leukemia The patient and/or family members do not agree to the treatment plan

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T cell injection targeting CD7 chimeric antigen receptor<br> | Drug: T cell injection targeting CD7 chimeric antigen receptor<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLT | Dose-limiting toxicity | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety results | Number of adverse events | Up to 2 years | 
| PK | The maximum concentration (Cmax） | Up to 2 years | 
| PD | Absolute value of CD7 Positive Cells in peripheral blood at each time point | Up to 2 years |