CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

This is an interventional treatment trial for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Read More

Inclusion Criteria:

1. Eastern cooperative oncology group (ECOG) performance status of 0 to 1；
2. Life expectancy ≥12 weeks;
3. Quantifiable tumor burden;
4. Understand and voluntarily sign the informed consent form.
5. Confirmed diagnosis of CD19+ relapsed/refractory B-ALL or B-NHL;
6. Adequate hematological, renal and liver function;
7. Female of childbearing age must agree to take effective contraceptive measures at least 1 year after infusion; Male with fertile partners must agree to use effective barrier contraceptive methods at least 1 year after infusion;

Exclusion Criteria:

1. Diagnosis of other malignancy (except for cured non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, ductal carcinoma in situ, or other malignancies that have completely responsed for more than 5 years);
2. Severe mental disorders;
3. History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome;
4. History of grade 2-4 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria);
5. Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstableangina pectoris, or other clinically prominent heart disease within one year before enrollment.
6. Subjects with CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases.
7. History or presence of CNS disorder, including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
8. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA;
9. There were active infections requiring systematic treatment in the 2 weeks prior to screening;
10. Severe Allergic subjects or subjects with allergic reactions to cyclophosphamide or fludarabine;
11. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years;
12. History or diagnosis of pulmonary fibrosis;
13. Subjects who received other clinical trial therapy within 4 weeks before participating in this trial, or the informed consent form was signed within the 5 half-life of the last administration in the other clinical trial (take longer time as standard);
14. Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan;
15. Subjects with comorbidities that require systemic corticosteroid therapy (≥5 mg/day of prednisone or an equivalent dose of other corticosteroids) or other immunosuppressive drugs within 1 months after study therapy according to the discretion of investigator;
16. Donor lymphocyte infusion 6 weeks prior to enrollment;
17. Pregnant women and lactating women who are reluctant to stop breastfeeding;
18. Any other conditions defined by researcher that is inappropriate for the subject to be enrolled;