Anti-CD7 Protein Expression Blocker (PEBL) Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)
The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).
• Diagnosis/ Disease define as:
‣ Relapsed T-cell acute lymphoblastic leukaemia/ lymphoma as defined by:
‣ Bone marrow disease = or \> 0.01% by MRD as determined by flow cytometry
‣ Or CNS disease as defined as \> 5 WBCs/ uL in CSF with morphological evidence of blasts or biopsy proven recurrence in the eye or brain
‣ Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites
⁃ Induction failure as defined by:
‣ MRD = or \> 1% by flow cytometry at the end of induction on day 33
‣ Or Failure to achieve morphological remission defined as \> 5% blasts after standard induction chemotherapy
⁃ Refractory disease as defined by:
‣ MRD = or \> 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy
• Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of \> 95% on room air
• Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening
• Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening
• Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening
• Alanine aminotransferase ≤ 5 times the upper limit of normal for age
• Patients with \> 99% CD7 expression on blast cells will be eligible for anti-CD7 PEBL-CAR-T cell infusion.