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T-lymphocyte infusion trial in patients with CD19 acute lymphoblastic leukemia resistant or refractory to treatment.
THE AIM OF THE TRIAL IS TO GET YOUR OWN WHITE BLOOD CELLS TO ATTACK ALL THOSE CELLS THAT EXPRESS A PROTEIN CALLED CD19 THAT IS PRESENT ON TUMOR CELLS. THESE MODIFICATIONS WILL BE MADE IN THE LABORATORY AND WILL ALTER THE GENES OF YOUR T LYMPHOCYTES. ONCE THE CELLS, WHICH WE WILL CALL ARI-0001, HAVE BEEN MODIFIED, THEY WILL BE INFUSED INTO YOUR VEIN. THE PURPOSE OF THIS STUDY IS TO DETERMINE IF THESE ARI-0001 CELLS ARE SAFE AND EFFECTIVE IN ERADICATING THE DISEASE.
Technical Summary
- PHASE 2 STUDY OF INFUSION OF AUTOLOGOUS DIFFERENTIATED PERIPHERAL BLOOD T LYMPHOCYTES EXPANDED AND TRANSDUCED WITH A LENTIVIRUS TO EXPRESS A CHIMERIC ANTIGENIC RECEPTOR WITH ANTI-CD19 SPECIFICITY (A3B1) CONJUGATED TO THE 4-1BB AND CD3Z CO-STIMULATORY REGIONS (ARI-0001 CELLS) IN PATIENTS WITH CD19 ACUTE LYMPHOBLASTIC LEUKEMIA RESISTANT OR REFRACTORY TO TREATMENT.
- Code EudraCT: 2019-003038-17
- Protocol number: CART19-BE-02
- Promoter: Institut de Investigacions biomediques august pi i sunyer
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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