This study is a single-arm, open-label, dose-escalation clinical trial to explore the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of the drug; The efficacy of the study drug in subjects with relapsed/refractory CD7-positive hematological malignancies, and the expression of B cells, T cells, and NK cell subtypes in peripheral blood were preliminarily observed. At the same time, explporing the distribution of anti-human CD7 CAR-NK cells in tumor tissues after administration of anti-human CD7 CAR-NK cell injection, and evaluating the immunogenicity of anti-human CD7 CAR-NK cell injection . To evaluate the correlation between the proportion of CD7-positive tumor cells and the safety and efficacy of anti-human CD7 CAR-NK cell injection and the evaluation. To explore the pharmacokinetics (PK) and pharmacodynamics(PD) characteristics of bone marrow in Chinese medicine.
Age 18-70 years old, gender is not limited;
The expected survival time exceeds 12 weeks;
ECOG score 0 to 2 points;
Recurrence criteria: ≥5% of the original cells appear in the bone marrow after hematologic remission (except for the hematopoietic recovery period after chemotherapy); or 2 peripheral blood samples at least one week intervals; or extramedullary lesions appear. Patients with early relapse (recuring within 12 months after the first remission) can be directly enrolled, while patients with advanced relapse (recuring after the first remission) need to rescue at least one course of chemotherapy through the original effective induction regimen and no remission is achieved; all relapse patients should include selectable targeted drugs for at least one course of treatment without remission. Allogeneic hematopoietic stem cells recur after transplantation, no other effective treatment options are available, and there is no active acute graft-versus-host disease (GVHD) above 2 degrees.
Use of immunosuppressive drugs or steroids within two weeks prior to cell collection, or the need for steroid or immunosuppressive drug use for more than two years.
History of malignancy other than hematologic neoplasms within five years before screening, except for adequately treated cervical carcinoma in situ, basal cell, or squamous cell skin cancer, localized prostate cancer after curative surgery, ductal carcinoma in situ after curative surgery, and thyroid cancer after curative surgery;
Active bacterial, viral, or fungal infections requiring treatment and not controlled; positive HBsAg or HBcAb (if positive, peripheral HBV-DNA testing is required with HBV DNA < detection limit to be eligible); positive HCV antibody with peripheral blood HCV RNA positivity; positive Treponema pallidum particle assay (TPPA); HIV antibody positivity;
Inadequate function of major organs (cardiovascular system, lungs), active gastrointestinal bleeding within the past three months; uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy; significant cardiovascular risk history or evidence including any of the following: congestive heart failure, unstable angina pectoris, clinically significant arrhythmias (such as ventricular fibrillation, ventricular tachycardia); history of arterial thrombosis formation within the last three months (such as stroke, transient ischemic attack); symptomatic deep vein thrombosis or pulmonary embolism within six months prior to enrollment; previous coronary angioplasty procedure; cardioversion by electric shock; any clinically relevant complications that may pose a risk to the safety of the subject or interfere with study assessments, procedures, or completion;
Single group
Anti-human CD7 CAR-NK cell injection
DrugAdminister anti-human CD7 CAR-NK cell injection on D0
Incidence of dose-limiting toxicity
To evaluate the incidence of DLT in patients with relapsed or refractory CD7-Positive Hematological Malignancies treated with anti-human CD7 CAR-NK cell injection, DLT is defined as any of the following events related to the study drug (including definitely related, probably related, and possibly related) that occurs within 14-28 days after the first dose of the investigational human CD7 CAR-NK cell injection (with appropriately extended observation duration for responders in dose groups showing therapeutic responses to assess whether DLT events resolve within the specified time frame), despite therapeutic interventions.
Incidence of adverse events
The occurence of study related adverse effects defined by NCI CTCAE5.0
Evaluate the number of CAR-NK cells in subjects' peripheral blood
Evaluate the number of Treg cells in subjects' peripheral blood after CD7 Car-NK cell injection administration
Analysis of the number changes of cytokine in peripheral blood.
Analysis of the number changes of cytokine in peripheral blood,Levels of related cytokines (such as IL-6);
Analysis of the number changes of lymphocyte subsets in peripheral blood.
Analysis of the number changes of lymphocyte subsets in peripheral blood, Including T/B/NK cells
Objective Response Rate (ORR)
To evaluate the efficacy of CD7 Car-NK cell injection of relapsed or refractory CD7-Positive Hematological Malignancies subjects.
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