Therapy in the US

Summary:
Relapsed acute lymphoblastic leukaemia (ALL) is difficult to treat, despite the already existing aggressive therapies, such as chemotherapy or radiation. In this case study Chimeric antigen receptor–modified T cells target directly Cancer Cells to destroy them. This phase 1 study proves that many restrictions of conventional therapies wrong and induces remission in patients with refractory diseases.

Methods:
All 30 patients in this phase 1 study (age 1-30 years) received chemotherapy before they have been infused with CD19-CAR T cells. First dose was 1 × 106 CAR-transmuted T-cells per body weight, the second dose was increased to 3 × 106 CAR-transmuted T-cells per body weight. After the dose-escalation phase an expansion cohort was treated with the maximum tolerated dose .The trial registration: ClinicalTrials.gov, number NCT01593696.

Results:
Between 2nd July 2012 and 20th June 2014, a total of 30 patients were enrolled and assessed for response (including eight previously had stem cell transplantation). These were infused with CD19-CAR T cells. A complete remission was achieved in 27 patients (90%). All toxicity and side effects were completely reversible.

Interpretation:
The chimeric antigen receptor-modified T cell therapy against CD19 cells revealed that treated patients suffering from relapsed and refractory ALL, could finally be effectively treated. Durable remissions could be observed up to 30 months. (Sponsored by Novartis; CART19 ClinicalTrials.gov number, NCT01626495 and NCT01029366).

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