This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of LstCAR019 injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).
Although the anti-CD19 CAR-T cell therapies have gained significant clinical outcome in patients with r/r B-ALL,autologous CAR-T is not feasible for some patients. To make further improvement, the investigators are going to conduct a clinical trial using universal CAR-T cells(LstCAR019) targeting CD19 for r/r B-ALL patients. After enrollment, patients will get a 3-5 days lymphodepletion therapy, then the LstCAR019 will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
LstCAR019 will be administered by vein. The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set:Dose level one: 1×10\^6 cells/kg;Dose level two: 2×10\^6 cells/kg;Dose level three: 5×10\^6 cells/kg. Each dose group requires at least three subjects. The trial will start from dose level one. The second portion includes a dosage extended cohort and will start after the finish of the"3+3"dose escalation study. Twelve subjects will get infusion of LstCAR019 at the best dose verified in the first portion.
Kunming Hope of Health Hospital
Kunming, Yunnan, China
Dose-limiting toxicity (DLT)
Neurotoxicity and/or CRS≥G3.
Time frame: Up to 28 days after LstCAR019 infusion
Incidence of Treatment Related adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Time frame: Up to 12 months after LstCAR019 infusion
Persistence of CAR-T cells
The persistence over time of CAR-T cells in the peripheral blood as determined by flow cytometry and qPCR.
Time frame: Up to 24 weeks after infusion
Objective response rate (ORR)
Patients who achieve CR(complete response) or CRi after infusion
Time frame: At 4 ,8 , 12 weeks after infusion
Progression-free survival (PFS)
Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause.
Time frame: Up to 24 weeks after infusion
Overall survival (OS)
Overall survival (OS) is the time from randomization to death from any cause.
Time frame: Up to 24 weeks after infusion
Duration of remission (DOR)
Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD.
Time frame: Up to 24 weeks after infusion
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