A Single Arm, Open-labelled Phase II Clinical Trial of Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) for Treatment of B-cell Haematological Malignancies
CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.
⁃ 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