CD19 positive B cell malignant tumor
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with relapsed/refractory CD19-positive B-cell malignancies, male or female, and those with poor prognosis of the currently available treatment options: 2. Age 18~70 years old (including the threshold), no gender limitation; 3. The expected survival time is not less than 2 months; 4. ECOG score 0-2 points; 5. A definite diagnosis of CD19-positive B-cell malignant tumor (CD19+ determination: ALL FCM (proportion >30%); NHL immunohistochemistry (positive)) and one of the following conditions: (1) Those who did not achieve complete remission after standard chemotherapy, or had early relapse after complete remission; (2) Those who relapse after stem cell transplantation are not affected by other treatment methods previously used; 6. Liver and kidney function, cardiopulmonary function meet the following requirements: (1) creatinine is within the normal range; (2) Left ventricular ejection fraction >50%; (3) Baseline oxygen saturation > 92%; (4) Total bilirubin <= 2 times the upper limit of normal; ALT and AST <= 2.5 times the upper limit of normal; 7. Be able to understand this test and have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with graft-versus-host disease (GVHD), or those who need to use immunosuppressive agents; 2. Malignant tumors other than B-cell malignancies within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, catheter after radical resection carcinoma in situ; 3. Subjects with hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer detection >=3x10^2/L; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; CMV DNA positive; syphilis positive; 4. Any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive Heart failure (New York Heart Association [NYHA] classification >= class III), severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; 5. Within 14 days before enrollment, there is active infection or uncontrollable infection requiring systemic treatment; 6. Pregnant or lactating women, 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. Other researchers think that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| partial response rate; | — |
Countries
China
Contacts
Public ContactXia Ruixiang
the First Affiliated Hospital of Anhui Medical University
Outcome results
None listed