CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Diagnosis/ Disease define as: 1. 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 2. 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 3. 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 echoca