This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.
Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA < 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ;
Uncontrolled active infection;
Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS;
Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) > 140mmHg and/or diastolic blood pressure > 90mmHg);
Single group
ThisCART19A
DrugThisCART19A is a new type CAR-T therapy for patients with ph+ ALL.
Fludarabine
DrugFludarabine is used for lymphodepletion.
Cyclophosphamide
DrugCyclophosphamide is used for lymphodepletion.
Olverembatinib
Druga third-generation TKI
Number of Participants with Complete Molecular Remission
Will be estimated along with the 95% credible intervals. Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.
Incidence of adverse events (AEs)
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
Objective Response Rate (ORR)
Will be estimated along with the 95% credible intervals. ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) .
Duration of Complete Molecular Remission
Will be estimated along with the 95% credible intervals.
Event-free survival (EFS)
The Kaplan-Meier method will be used to assess EFS probabilities.
Overall survival (OS)
The Kaplan-Meier method will be used to assess OS probabilities.
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The First Affiliated Hospital of Soochow University
Lead sponsor
Fundamenta Therapeutics, Ltd.
Collaborator
