A Randomized, Double-Blind, Positive-Controlled, Multicenter Clinical Study to Compare the Similarities in Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Injectable BLB101 and Blincyto® in Adult Participants with R/R CD19+ B-ALL. Provide evidence for the approval and marketing of the drug for its targeted indication.
Primary Objectives:
Primary Endpoints:
This study plans to enroll approximately 212 participants, who will be randomized at a 1:1 ratio into the following two groups:
Test group: BLB101 for injection Control group: Blinatumomab for injection (Blincyto®) A stratified block randomization method will be adopted. The randomization stratification factors are as follows:a) Creatinine clearance (≤90 mL/min vs >90 mL/min);b) Baseline leukemic cell proportion (≤50% vs >50%);c) Relapsed/refractory status (first relapse vs ≥2 relapses or refractory disease).
For each participant, the overall study procedure is outlined as follows: Participants will receive treatment with either BLB101 for injection or Blincyto®. Each treatment cycle consists of 6 weeks, including 4 weeks of dosing followed by a 2-week treatment-free interval. Each participant is required to complete the first 2 induction treatment cycles (i.e., an induction treatment period of up to 12 weeks), after which the participant will be considered to have fulfilled the primary study objectives.
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be included in this study:
Exclusion Criteria:
Participants who meet any of the following criteria are not eligible to be included in this study:
BLB101 for injection administered via intravenous infusion at a dose of 9μg/d or 28 μg/d. One treatment cycle consists of 6 weeks, including 4 weeks of dosing followed by a 2-week treatment-free interval.Participants weighing ≥45kg received fixed dosing: In Induction Cycle 1: 9μg/d on Days1-7, followed by 28μg/d on Days 8-28, then a 14-day treatment-free period.In Induction Cycle 2: 28μg/d on Days 1-28, followed by a 14-day treatment-free period.For participants weighing \<45kg, doses were calculated by body surface area (BSA): Induction Cycle 1: 5μg/m²/d (max 9μg/d) on Days1-7, 15μg/m²/d (max 28μg/d) on Days8-28, followed by a 14-day treatment-free period; Induction Cycle 2: 15μg/m²/d (max 28μg/d) on Days1-28, followed by a 14-day treatment-free period.
Blinatumomab for injection administered via intravenous infusion at a dose of 9μg/d or 28 μg/d. One treatment cycle consists of 6 weeks, including 4 weeks of dosing followed by a 2-week treatment-free interval.Participants weighing ≥45kg received fixed dosing: In Induction Cycle 1: 9μg/d on Days1-7, followed by 28μg/d on Days 8-28, then a 14-day treatment-free period.In Induction Cycle 2: 28μg/d on Days 1-28, followed by a 14-day treatment-free period.For participants weighing \<45kg, doses were calculated by body surface area (BSA): Induction Cycle 1: 5μg/m²/d (max 9μg/d) on Days1-7, 15μg/m²/d (max 28μg/d) on Days8-28, followed by a 14-day treatment-free period; Induction Cycle 2: 15μg/m²/d (max 28μg/d) on Days1-28, followed by a 14-day treatment-free period.
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