Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies

Prior treatment

• Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression

Other illness

• Patients with active infection
• Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
• Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage, dementia, paralysis)
• Patients who are positive for HBsAg, HCV RNA positive or with HIV infection
• Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy.

Lab values

• Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion
• Cardiac function: Fractional shortening \<28% or left ventricular ejection fraction \<45% by echocardiography.
• Renal function: Creatinine clearance \<50 mL/min/1.73 m2
• Liver function: Patients with a serum bilirubin \>3 times upper limit of normal or an AST or ALT \> 5 times upper limit of normal, unless due to leukaemic liver infiltration in the estimation of the investigator

Other

• Pulmonary function: Grade 1 dyspnea and pulse oxygenation \> 91% on room air

• Acute Lymphoblastic Leukaemia
• Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or relapse after prior stem cell transplant, or persistent Minimal Residual Disease (MRD) positive disease
• ECOG performance score of ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening
• Post allogeneic stem cell transplant patients with B cell ALL will be eligible \> 3 months after transplant and off immunosuppression for at least 1 month.
• Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,
• For women of childbearing potential, a negative pregnancy test prior to apheresis
  • B-cell lymphoma
• Patients with histologically confirmed refractory Diffuse Large B-cell Lymphoma, primary mediastinal B cell lymphoma or transformed follicular lymphoma or other B-cell lymphoma according to WHO classification
• Confirmed CD19 positivity status in tissue sample obtained at diagnosis or relapse
• Received at least two prior treatment which must include at least one intensive systemic therapy.
• Disease progression or relapsed disease within 12 months after autologous stem cell transplant
• ECOG performance score of ≤2 if \>16 years old, or Lansky performance score of \>50 if ≤16 years old at screening
• Has sufficient organ function to tolerate treatment with CAR-T cell therapy
• For women of childbearing potential, a negative pregnancy test prior to apheresis