CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia

Inclusion Criteria24

• 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.
• Patients who test positive on urine pregnancy testing and are pregnant or are lactating
• Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome
• Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease
• Active or latent hepatitis B or hepatitis C infections within 8 weeks of screening, or any uncontrolled infection at screening
• Positive Human Immunodeficiency Virus (HIV) test within 8 weeks of screening
• Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD
• Received an investigational medicinal product within 30 days of screening
• Central nervous system : Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure \> 20 cm water; decreased conscious state (any cause)