CD22-positive hematological malignancies
Conditions
Interventions
experimental group:Glyco-engineered NK cells
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2020 first edition) and acute B lymphocytic leukemia clinical practice guidelines (2018 first edition), the diagnosis of hematological tumors (including Acute B-lymphocytic leukemia and B-cell lymphoma) patients. 2. Subjects with acute B-lymphocytic leukemia (B-ALL) must meet one of the following conditions before screening: 1) refractory (defined as: complete remission after 2-line standard treatment); 2) systemic treatment (2 lines or above) after recurrence. 3. B-ALL subjects must meet all of the following conditions before screening: 1) The number of bone marrow morphological primitive cells >= 5%; 2) Ph+ acute lymphoblastic leukemia that cannot tolerate more than two TKI inhibitors or is resistant to them Subjects (Ph+ ALL subjects or Ph- subjects with T315i mutation do not require the use of their TKI). 4. B-cell lymphoma patients who need to undergo at least second-line treatment (a standard chemotherapy regimen + a rescue chemotherapy) before screening for B-cell lymphoma patients who have failed or recurred. 5. According to the Lugano standard in 2014, patients with B-cell lymphoma have at least one measurable lesion with the longest diameter >= 1.5 cm; there is no requirement for B-ALL subjects. 6. Aged 14 to 80 years old; 7. Bone marrow or peripheral blood or immunohistochemical or pathological results show CD22 positive, and the current clinical practice is not suitable for sampling. The test results within 60 days before signing and knowing can be accepted. The investigator will determine whether it can be included in the group. 8. The expected survival time is >= 12 weeks. 9. No obvious functional diseases such as liver, kidney, heart, etc. 10. ECOG score 0-2 points. 11. The subject has no active lung infections. 12. There is no contraindication for peripheral blood apheresis. 13. The subject and his spouse agree to take effective tools or contraceptive measures within one year after the subject signs the informed consent to the infusion of glycoengineered NK cells; female subjects of childbearing age are tested for serum or urine pregnancy during the screening period Must be negative. 14. Volunteer to participate in this trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Severe active infections (except for simple urinary tract infections and bacterial pharyngitis), or are currently receiving intravenous antibiotic therapy, or subjects who have received intravenous antibiotic therapy within 1 week before cell infusion. However, preventive antibiotics, antiviral and antifungal infection treatments are permitted. 3. Use systemic steroids; recent or current use of inhaled steroids is not excluded. 4. The CAR-T cell therapy that has participated in the past produces any uncontrolled diseases. 5. Subjects who have received allogeneic hematopoietic stem cell transplantation. 6. Central nervous system diseases that have nothing to do with B-lymphocyte tumor central invasion (such as cerebral aneurysm, epilepsy, stroke, Alzheimer's, mental illness, etc.). B-lymphocyte tumor central invasion or digestive tract invasion is not considered as an exclusion criterion, but whether to enter the group is determined by the investigator. 7. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the detection value of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 IU/mL. 8. Patients with hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive. 9. Subjects with other acquired and congenital immunodeficiency diseases, including but not limited to human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; syphilis test positive. HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall remission rate;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactZhao Mingfeng
Tianjin First Central Hospital
Outcome results
None listed