Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTL019 · 4 trials · 3 indications
Percentage of participants with Serious AEs (SAEs) and non-SAEs
Treatment emergent adverse events were collected from CTL019 infusion until end of study, up to 12 months
DFS is defined as the time from the date of tisagenlecleucel infusion to the date of the first documented morphological relapse, occurrence of secondary malignancy or death due to any cause. Participants are not censored at the start of subsequent anticancer therapy or SCT while in remission.
OS is defined as the time from date of first tisagenlecleucel infusion to the date of death due to any reason.
Evaluating the efficacy of tisagenlecleucel therapy from all manufacturing facilities as measured by overall remission rate (ORR) during the 3 months after tisagenlecleucel administration. ORR included complete response (CR) and CR with incomplete blood count recovery (CRi) as determined by an Independent Review Committee assessment. Per response criteria defined by National Comprehensive Cancer Network (NCCN), American Society of Hematology (ASH) and International Working Group (IWG) guidelines. CR is defined as: Bone marrow \<5% blasts, Peripheral blood: Neutrophils \>1.0 x 10\^9/L, and Platelets \>100 x 10\^9/L and Circulating blasts \<1% and No evidence of extramedullary disease, at least 7 days transfusion independency. CRi is defined as all the prior criteria being met, except that the following exists: Neutrophils ≤1.0 x 10\^9/L, and/or Platelets ≤100 x 10\^9/L, and/or Platelet and/or neutrophil transfusions ≤7 days before the date of the peripheral blood sample for disease assessment.
| Arm | Type | Description |
|---|---|---|
| Group A: pALL | EXPERIMENTAL | Pediatric/young adult patients with r/r pALL who meet the indication in the Health Authority-approved CTL019 package insert in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient. |
| Group B: r/r LBCL | EXPERIMENTAL | Adult patients with r/r LBCL including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, that is consistent with the Health Authority-approved indication in the package insert for CTL019 in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient. |
| Group C: r/r NHL | EXPERIMENTAL | Adult patients with r/r NHL in consistent with the Health Authority approved indication in the package insert for CTL019 in Japan whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient. |
| CTL019 | EXPERIMENTAL | CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg) |
| Single dose of CTL019 | EXPERIMENTAL | Based on the subject's weight one of two possible dose ranges will be prepared for the subject: Subjects ≤ 50 kg: 0.2 to 5.0 x 10(6) CAR-positive viable T cells per kg body weight OR Subjects \> 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells |
| Name | Type | Description |
|---|---|---|
| CTL019 | BIOLOGICAL | A single intravenous (i.v.) infusion of CAR-positive viable T cells. |
Key inclusion criteria: * Signed informed consent/assent must be obtained for this study prior to participation in the study. * Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications. * Not excluded from commercial manufacturing under t...
CTL019 is an investigational chimeric antigen receptor T-cell therapy being developed for B-cell acute lymphoblastic leukemia and acute lymphoblastic leukemia. It is a monoclonal antibody-based treatment that targets CD19-positive cancer cells. The drug is currently in Phase 3 clinical development for these indications.
CTL019 targets CD19, a protein expressed on the surface of B-cells, including malignant B-cells in acute lymphoblastic leukemia. By engineering a patient's T-cells to express a chimeric antigen receptor specific to CD19, the therapy directs the immune system to recognize and eliminate CD19-positive leukemia cells.
CTL019 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of this therapy in patients with B-cell acute lymphoblastic leukemia and acute lymphoblastic leukemia.
CTL019 is currently in Phase 3 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The drug is being studied in multiple trials, including Phase 2 and Phase 3 studies, to assess its efficacy and safety in patients with acute lymphoblastic leukemia.
CTL019 is being evaluated in several clinical trials, including NCT02435849, a completed Phase 2 study in pediatric patients with B-cell acute lymphoblastic leukemia; NCT03123939, a completed Phase 3 study in acute lymphoblastic leukemia; NCT03876769, an active Phase 2 study in high-risk B-ALL patients with minimal residual disease; and NCT04094311, a recruiting Phase 3 study in B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma.
Yes, CTL019 is also known as tisagenlecleucel. Clinical trial NCT03876769 and NCT04094311 refer to tisagenlecleucel in their titles, confirming that CTL019 and tisagenlecleucel are the same drug. This therapy is being developed by Novartis for the treatment of B-cell malignancies.