R/R CD19-positive B-cell Malignant Tumors
Conditions
Interventions
Group 4 :Select the above optimal dose for a single dose
Sponsors
The Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects with relapsed/refractory CD19-positive B-cell malignancies, male or female, who have a poor prognosis with the currently available treatment options: 1. Aged 18 to 70 years old; 2. The expected survival time is not less than 2 months; 3. ECOG score 0-2 points; 4. Definitely diagnosed as CD19-positive B-cell malignant tumor (CD19+ confirmed: ALL FCM (proportion>30%); NHL immunohistochemistry (positive)) and meet one of the following conditions: (1) Those who have not achieved complete remission after at least 2 courses of standard induction chemotherapy, or who relapse early after complete remission, or late relapse after complete remission, and who have not achieved complete remission after standard 1 course of induction chemotherapy; (2) Those who relapse after stem cell transplantation will not be affected by other treatments previously used; 5. Liver and kidney function, heart and lung function meet the following requirements: (1) Creatinine is within the normal range; (2) Left ventricular ejection fraction>50%; (3) Baseline blood oxygen saturation>92%; (4) Total bilirubin <=2 ULN; ALT and AST <=2.5 ULN; 6. Able to understand this experiment and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents; (2) Patients with malignancies other than B-cell malignancies within 5 years before screening, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ; (3) Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer test >=1x10^2 copies/L; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; CMV DNA test positive; syphilis test positive; (4) Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestion Heart failure (New York Heart Association [NYHA] classification >=grade III), severe arrhythmia requiring medication, liver, kidney or metabolic diseases; (5) Within 14 days before enrollment, there are active infections or uncontrollable infections requiring systemic treatment; (6) Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 1 year after cell reinfusion, or male subjects whose partners plan to become pregnant within 1 year after cell reinfusion; (7) Invasion of the central nervous system; (8) Situations deemed unsuitable by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS;OS; | — |
Countries
China
Contacts
Public ContactWenyu Shi
Affiliated Hospital of Nantong University
Outcome results
None listed