A Study of Injectable BLB101 and Blincyto® in Adult Participants With R/R CD19+ B-ALL (NCT07723911) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Injectable BLB101 and Blincyto® in Adult Participants With R/R CD19+ B-ALL
212 participantsStarted 2026-08-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. The number of previous treatment lines is 1 to 2, and it meets the definition of relapse or refractory (any of the following conditions can be included in the group: ① Late relapse: Reversal after achieving remission with previous treatment and duration ≥ 12 months; ② Early relapse: Remission achieved with previous treatment and duration \< 12 months; ③ Refractory: Failure to achieve remission during the first induction or salvage treatment; ④ Recurrence after transplantation: Recurrence at any time after hematopoietic stem cell transplantation);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial comparing an injectable form of BLB101 to Blincyto — since my leukemia is relapsed or refractory, is one of these approaches likely to offer me a meaningful advantage over the other, or would standard salvage chemotherapy still be worth trying first?
2The trial isn't recruiting yet — given how quickly R/R B-ALL can progress, do you think it's realistic for me to wait for this study to open, and how would we decide when to move forward with another option if enrollment is delayed?
3This study is measuring drug exposure levels like Css and AUC alongside remission rates — what does that combination tell us about what researchers are still trying to figure out about BLB101, and are there unknowns about its safety profile that I should be aware of?
4Blincyto is already an approved treatment for my type of leukemia — if I were assigned to the BLB101 arm, what is actually different about it compared to Blincyto, and does the injectable formulation change how it's given or how often I'd need to come in for treatment?
5Since this trial targets CD19-positive B-ALL specifically, how confident are you that my leukemia still expresses CD19, and could prior treatments I've already received have affected that in a way that would matter for whether this trial is even worth considering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Css
Timeframe: Cycle 1(Cycle 1=28 days), Day 8, Day 14, Day 21, Day 28, Day 29
2
AUC0-24,d1
Timeframe: Cycle 1(Cycle 1=28 days), predose and up to 24 hourspost-dose
3
CR/CRh
Timeframe: End of Cycle 1 and up to (+7) days (Cycle 1=28 days); End of Cycle 2 and up to (+7) days (Cycle 2=28 days)
Trial details
NCT IDNCT07723911
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Organ function requirements: Liver and kidney function: ALT/AST ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN; Creatinine clearance rate ≥ 60 mL/min; Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, no severe arrhythmia;
Exclusion criteria
. 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;
. Participants with Burkitt lymphoma/leukemia;
. Participants with isolated extramedullary disease recurrence and active ALL in the testicles;
. Participants who have received targeted CD19 anti-tumor therapy before and have a proportion of CD19-positive leukemia cells \< 50%;
. Participants who have received at least 28 days of targeted CD19 bispecific antibody treatment and have been ineffective (ineffectiveness is defined as the failure to achieve CR or CRh or CRi or MLFS in the efficacy evaluation);