CHP 959 - A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leukemia and Lymphoma

Trial Profile

CHP 959 - A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leukemia and Lymphoma

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Jul 2017

At a glance

  • Drugs Tisagenlecleucel-T (Primary)
  • Indications Acute lymphoblastic leukaemia; B cell prolymphocytic leukaemia; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Non-Hodgkin's lymphoma
  • Focus Adverse reactions
  • Acronyms Pedi CART19
  • Most Recent Events

    • 12 Jul 2017 According to a Novartis media release, the US FDA Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
    • 02 Jun 2017 Results (n=10) assessing effect of CAR-T cells on responses in children with non-CNS extramedullary relapse of CD19+ acute lymphoblastic leukemia using patient data from NCT01626495 and NCT02374333 trials, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 29 Mar 2017 According to a company media release, the US FDA has accepted Novartis' BLA filing and granted priority review for CTL019 (tisagenlecleucel-T) in relapsed and refractory pediatric and young adult patients with B-cell ALL. The priority review designation and BLA submission for CTL019 is based on the results from this and two other trials (CT profiles 256762 and 248854).
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