Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTL019 T-cells · 1 trial · 3 indications
ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and cerebrospinal fluid (CSF). This primary endpoint was based on the local investigator assessment. No participants with lymphoblastic lymphoma were infused in this study.
| Arm | Type | Description |
|---|---|---|
| tisagenlecleucel (CTL019) | EXPERIMENTAL | Pediatric patients with relapsed/refractory B-cell ALL |
| Name | Type | Description |
|---|---|---|
| CTL019 T-cells | BIOLOGICAL | A target dose of CTL019 transduced cells will consist of a single infusion of 2.0 to 5.0 x 10\^6 CTL019 transduced cells per kg body weight (for patients ≤ 50 kg) and 1.0 to 2.5 x 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg). The following cell dose ranges may be infused if all other safety release criteria are met: 0.2 to 5.0 x 10\^6 CTL019 transduced viable T cells per kg body weight (for patient ≤ 50 kg) and 0.1 to 2.5 x 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg). |
Inclusion Criteria: * Relapsed or refractory pediatric B-cell ALL and lymphoblastic lymphoma: 1. 2nd or greater Bone Marrow (BM) relapse OR 2. Any BM relapse after allogeneic SCT and must be \> 6 months from SCT at the time of CTL019 infusion OR 3. Refractory as defined by not achieving a CR...
CTL019 T-cells is an investigational cell therapy being studied for B-cell Acute Lymphoblastic Leukemia, including relapsed and refractory forms of the disease. It is being developed by Novartis AG and is currently in Phase 2 clinical development.
CTL019 T-cells is being developed by Novartis AG, a company traded on the New York Stock Exchange under the ticker NVS. The therapy is currently in Phase 2 clinical development for B-cell Acute Lymphoblastic Leukemia.
CTL019 T-cells is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. A Phase 2 clinical trial for the therapy has been completed.
CTL019 T-cells has been studied in a completed Phase 2 clinical trial with the identifier NCT02228096. The trial, titled "Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients," enrolled 75 participants in the United States and included patients aged 3 years and older.
CTL019 T-cells is classified as a monoclonal antibody modality, though it is an investigational cell therapy. It is being studied for the treatment of B-cell Acute Lymphoblastic Leukemia, including relapsed and refractory cases, and is currently in Phase 2 development.