Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Infusion of JY231 Injection by dose of 1-10×10\^6 Transduction Units (TU)/kg、1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)
920th HJointLogistics
Kunming, Yunnan, China
RECRUITINGIncidence 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 infusion
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Time frame: Up to 28 days after infusion
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
Time frame: At 2,4,8 and 12 weeks after infusion
Best Overall Response
The optimal degree of disease status improvement achieved by the patient over the course of the entire clinical trial or treatment period.
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 2 years after infusion
Time To Progression (TTP)
The duration from the initiation of treatment until the first occurrence of objective disease progression.
Time frame: Up to 2 years 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.
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Time frame: Up to 2 years after infusion
Overall survival (OS)
Overall survival (OS) is the time from randomization to death from any cause.
Time frame: Up to 2 years after infusion