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;