This is a non-randomized, open label, single-site, dose-escalation study in up to 20
participants with relapse/refractory NHL. This study aims to evaluate the safety and efficacy
of the treatment with Quikin CD19-CART.
Quikin CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene
integration and also PD1 knockout by one-step gene-editing. After completion of study
treatment, subject participation for this study will be followed up to 15 years after
completion of study treatment.
Inclusion Criteria:
1. Have the capacity to give informed consent;
2. ALL patients with the age between 18 and 65;
3. Expected survival >3 moths;
4. With no severe heart and lung disease;
5. Previously confirmed diagnosis as CD19+ B-ALL or NHL within 6 months;
6. Hematological index as following, white blood cell (WBC)≥1.5×10^9/L，absolute
neutrophil count (ANC) ≥0.8×10^9/L, Platelet count≥50×109/L, Hemoglobin (Hgb) ≥
90mg/L, lymphocyte count≥ 0.4×10^9/L；
7. Blood biochemical index as no more than 1.5* ULN, including total bilirubin (TBIL),
transglutaminase (AST), alanine aminotransferase (AST), Creatinine (SCr), Urea in
patients with no tumor metastasis in liver and kidney; Blood biochemical index no more
than 5* ULN in patients with tumor metastasis in liver and kidney;
8. With a stable cardiac function, the left ventricular ejection fraction (LVEF) ≥ 55%;
9. Virological tests were negative for EBV, CMV, HIV, TP and HCV; a negative HBV DNA test
is acceptable if HBsAg is positive;
10. ECOG <2;
11. Relapsed or refractory (r/r) NHL including, Diffuse large B cell lymphoma(DLBCL, NOS),
stage Ⅲ-Ⅳ;Primary mediastinal large B-cell lymphoma (PMBL), stage Ⅲ-Ⅳ; High grade
B-cell lymphoma (HGBL), stage Ⅲ-Ⅳ; Mantle cell lymphoma (MCL), stage Ⅲ-Ⅳ; follicular
lymphoma (FL), stage Ⅲ-Ⅳ and with aggression. r/r NHL defined as following,
demonstrate disease that persists or relapse after achieving complete response (CR)
after > 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic
stem cell transplantation (auto-HSCT), or not achieving CR after auto-HSCT.
Exclusion Criteria:
1. Pregnant or lactating women;
2. With a pregnancy plan in the next 2 years;
3. Prior treatment of anti-GVHD therapy;
4. Acceptance of allogeneic stem cell transplant (ASCT);
5. Isolated extramedullary relapse of ALL;
6. Severe mental disorders, active autoimmune diseases, active infectious diseases,
severe cardiovascular diseases;
7. Partial prothrombin time or activated partial thromboplastin time or international
standardized ratio > 1.5*ULN without anticoagulant treatment;
8. History of other type of maligant tumors;
9. Any circumstances that possibly increase the risk of subjects or interfere with study
results, which judged by investigator.
