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A Study of Injectable BLB101 and Blincyto® in Adult Participants With R/R CD19+ B-ALL

NCT07723911 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-07-23

No results posted yet for this study

Summary

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：

1. To compare the pharmacokinetic similarity between Injectable BLB101 and Blincyto® in participants with R/R B-ALL.
2. To compare the efficacy similarity between Injectable BLB101 and Blincyto® in participants with R/R B-ALL.

Primary Endpoints:

1. Css and area AUC0-24,d1 of Injectable BLB101 versus Blincyto® in participants with R/R B-ALL.
2. CR/CRh within the first two induction cycles of treatment with Injectable BLB101 and Blincyto® in participants with R/R B-ALL, as assessed by the IRC per the response criteria for ALL.

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.

Conditions

  • Precursor B-cell Acute Lymphoblastic Leukemia

Interventions

DRUG

BLB101 for Injection

BLB101 for Injection;Administration route: Intravenous infusion; Dose: 9 μg/day or 28 μg/day;Drug administration schedule: Each 6-week period constitutes a treatment cycle. During each cycle, the drug is administered for 4 weeks and then the drug is withheld for 2 weeks. Each participant is required to complete the first 2 treatment cycles. After completing the first 2 induction treatment cycles (i.e., a maximum of 12 weeks of treatment), they will be considered to have fulfilled the main research objective of this study. After 2 cycles of induction treatment, the decision will be made by the investigators based on the specific clinical circumstances.

DRUG

Blinatumomab for Injection

Blinatumomab for Injection (Blincyto),Administration route: Intravenous infusion; Dose: 9 μg/day or 28 μg/day;Drug administration schedule: Each 6-week period constitutes a treatment cycle. During each cycle, the drug is administered for 4 weeks and then the drug is withheld for 2 weeks. Each participant is required to complete the first 2 treatment cycles. After completing the first 2 induction treatment cycles (i.e., a maximum of 12 weeks of treatment), they will be considered to have fulfilled the main research objective of this study. After 2 cycles of induction treatment, the decision will be made by the investigators based on the specific clinical circumstances.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-09
Primary Completion
2027-10-10
Completion
2028-10-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723911 on ClinicalTrials.gov