This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ Leukemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR Tcells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ Leukemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Adverse events of each patient
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time frame: 3 years
Survival time of Anti-CD19 CAR T cells in vivo
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Time frame: 3 years
Antitumor Effects
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time frame: Every 3 months post treatment up to 24 months
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time frame: 4 weeks
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