A Study of Injectable BLB101 and Blincyto® in Adult Participants With R/R CD19+ B-ALL
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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.
Eligibility criteria
Qualifiers
Before the trial began, the trial details were known, and the participant understood and voluntarily signed the Informed Consent Form (ICF);
Age ≥ 18 years old;
Confirmed as Philadelphia chromosome (Ph) negative and CD19 positive relapsed/refractory B-ALL (must meet: ① Through morphological and local flow cytometry immunophenotype assessment, there are expressed CD19 primitive immature cells in peripheral blood or bone marrow, confirming the current state of relapse, and there are relevant medical records to support; ② The proportion of primitive cells in the bone marrow is greater than 5% (measured by morphology); ③ Chromosome karyotype analysis or FISH analysis or PCR or NGS confirms Ph-negative), the Ph status needs to be reconfirmed before enrollment;
ECOG ≤ 2 points;
Disqualifiers
Participants with negative CD19 in ALL;
Participants with Ph-positive ALL or mixed phenotype;
Pregnant or lactating women;
Active central nervous system (CNS) leukemia (cerebrospinal fluid white blood cells ≥ 5/μL and leukemia cells are observed); those with a history of CNS disease who have received effective treatment and achieved remission are excluded;
Trial design
Treatments tested in this trial
- BLB101 for Injection
- Blinatumomab for Injection
Treatment groups
212 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov