This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
Must be an adult 18 years of age or older.
Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia.
Patients must be in a complete remission with Minimal Residual Disease (MRD) following an induction regimen. MRD is defined herein as a bone marrow biopsy with fewer than 5% lymphoblasts. Complete remission implies the resolution of any extramedullary and/or Central Nervous Syndrome (CNS)-2-3/parenchymal disease.
Be willing and able to provide written informed consent/assent for the trial.
Diagnosis of L3 type Burkitt's lymphoma, Mixed-Lineage Leukemia (MLL) rearranged leukemia, biphenotypic leukemia, mixed phenotype acute leukemia, blast phase of chronic myeloid leukemia, or stem-cell leukemia.
Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severe Congestive Heart Failure (CHF).
Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
Single group
Tecartus
DrugTecartus is a CD19 directed CAR T-cell therapy that utilizes CD28 costimulatory and CD3 zeta stimulatory domains. Tecartus is manufactured from purified autologous T-cells via retroviral transduction with a median time to product release of 13 days.
Relapse Free Survival (RFS)
The primary endpoint is RFS, defined as the time from KTE-X19 infusion until clinical relapse or death from any cause. Patients proceeding to subsequent anti-cancer therapy, inclusive of allogeneic transplantation, without relapse will be censored in this analysis. Surviving patients not meeting criteria for relapse by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Molecular Response Rate
Measured as converting to a complete molecular remission following CAR T-cell immunotherapy. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.
Clinical Relapse Rate
Measured as \>5% lymphoblasts in the bone marrow and/or the emergence of extramedullary leukemia.
Molecular Relapse Rate
Measured as achieving complete molecular remission at day 28 and followed until 5 years from infusion or the emergence of detectable disease. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.
Duration of Response (DOR)
Measured as time from enrollment until clinical relapse or death. In the case of death without documented relapse, patients will be censored.
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Kite, A Gilead Company
Collaborator
