Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies

Prior treatment

• Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II, Modified Glucksberg criteria) or moderate/severe chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids
• Patients receiving corticosteroids at a dose of \>5 mg prednisolone per day (or equivalent) that cannot be discontinued

Other illness

• CD19 negative disease
• Active CNS involvement of disease
• Active hepatitis B, C or HIV infection

Lab values

• Bilirubin \>2 x upper limit of normal
• GFR \<30ml/min
• Known allergy to albumin or DMSO
• Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction \<40%

Other

• Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma
• Oxygen saturation ≤ 90% on air
• Women who are pregnant or breast feeding
• Karnofsky score \<60%
• Life expectancy \<3 months
• Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial\*
  • These patients will be initially considered for autologous treatment in preference to enrolling on KCAT19

• Age 16-65 years
• Relapsed or refractory B cell malignancy following at least 2 prior lines of therapy:
  • B-ALL: relapsed or refractory B-ALL following standard therapy, requiring salvage, in whom alternative therapies are deemed inappropriate by their treating physician Or LBCL: relapsed/refractory DLBCL (incl. transformed FL but not Richter's transformation) or PMBCL following ≥2 prior lines of therapy which must include Rituximab, anthracycline and autologous CD19 CAR, (unless CD19 CAR cannot be manufactured) Or MCL: relapsed/ refractory disease following ≥2 lines of therapy which must include Rituximab, Bruton's tyrosine kinase inhibitor and autologous CD19CAR therapy (unless CD19 CAR cannot be manufactured) Or Indolent B-NHL (either Follicular Lymphoma, Marginal Zone Lymphoma or other low-grade lymphoma) which is relapsed / refractory following ≥2 prior lines of therapy which must include anti-CD20 therapy and chemotherapy with anthracycline or bendamustine.
• CD19+ disease
• Agreement to have a pregnancy test, use adequate contraception (if applicable)
• Written informed consent