CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma, Diffuse Large B Cell Lymphoma
About this trial
This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria: 14 years to 85 years, expected survival > 3 months; CD19/CD22 positive B-cell lymphoma or B-ALL; relapsed or refractory to standard first-line treatment; ECOG-PS score=0-2; Having at least one measurable lesions; Cardiac function: 1-2 levels; Liver: TBIL≤3ULN,AST ≤2.5ULN,ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L; No serious allergic constitution; No other serious diseases that conflicts with the clinical program; No other cancer history; No serious mental disorder; Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); Uncontrolled active infection, HIV infection, syphilis serology reaction positive; Active hepatitis B or hepatitis C infection; Recent or current use of glucocorticoid or other immunosuppressor; With severe cardiac, liver, renal insufficiency, diabetes and other diseases; Participate in other clinical research in the past three months; previously treatment with any gene therapy products; Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
Sites / Locations
- Liang WangRecruiting
Arms of the Study
Arm 1
Experimental
CD19/CD22 CAR-T group
Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19-CAR-T cell was 2×10e6/kg and CD22-CAR-T cell was 1×10e6/kg. Both CAR-T cells were infused at the same day.