A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- NHL

Who may be able to join

• Aged 18-70 years;
• Relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL): 1) Chemotherapy-refractory disease, defined as one or more of the following: a) No response to first-line therapy (primary refractory disease, subjects who are intolerant to first-line therapy chemotherapy are excluded): i. PD as the best response to first-line therapy; ii.SD as the best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) with SD duration no longer than 6 months from last dose of therapy; b) No response to second or greater lines of therapy: i. PD as the best response to most recent therapy regimen; ii. SD as the best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy; c) Refractory post-ASCT(autologous stem cell transplantation): i. Disease progression or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects); ii. If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy; d) PD or SD as the best response after previous CAR-T therapy (at least 3 months ago); 2) Subjects must have received adequate prior therapy including at a minimum: anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and an anthracycline containing chemotherapy regimen; for subjects with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemotherapy-refractory disease after transformation to DLBCL; 3) At least 1 measurable lesion according to the Lugano Response Criteria (Cheson 2014). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy: a) For nodular lesions, longest diameter ≥15mm, no requirement for shortest diameter; b) For extranodal lesions (lesions other than lymph node and nodular lesions, including liver and spleen), longest diameter ≥10mm, no requirement for shortest diameter;
• ECOG performance status ≤2 score;
• Life expectancy≥12 weeks;
• CD19 and/or CD22 positive expression demonstrated in tumor tissue;
• Adequate organ function defined as: 1) Creatinine clearance (as estimated by Cockcroft Gault method)>60 mL/min; for male, creatinine clearance=[ (140-age)×weight(kg)]/[0.818×creatinine (μmol/L)] ; for female, creatinine clearance =[(140-age)×weight(kg)×0.85]/[0.818×creatinine (μmol/L)]; 2) Serum ALT/AST<2.5×ULN (for subjects with liver metastases, ALT/AST≤5×ULN); 3) Total bilirubin<1.5×ULN (for subjects with Gilbert's syndrome, total bilirubin≤ 3×ULN); 4) Left ventricular ejection fraction (LVEF)>50%, no evidence of clinically significant pericardial effusion as determined by an ECHO; 5) No clinically significant pleural effusion; 6) Baseline oxygen saturation >92% on room air;