Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319) (NCT07371533) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319)
18 participantsStarted 2026-02-02
Plain-language summary
This is an exploratory study with an open-label, single-arm, single-center design. It plans to enroll subjects with refractory/relapsed acute B-cell lymphoblastic leukemia (B-ALL), or treatment-naive or previously treated B-ALL subjects who achieved complete remission (CR) after induction chemotherapy but still have positive minimal residual disease (MRD). The primary objectives are to preliminarily evaluate the safety, tolerability, pharmacokinetics, biology, preliminary efficacy, and immunogenicity of A-319 subcutaneous injection.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
All of the following criteria must be met for refractory/relapsed acute B-cell lymphoblastic leukemia:
* 1.Aged 18 to 75 years (inclusive), regardless of gender;
* 2.Confirmed diagnosis of refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL) with positive CD19 expression. Definition of refractory or relapsed: failure to respond to conventional induction chemotherapy; early relapse (relapse within 12 months of first remission); relapse after 12 months of first remission with failure to achieve remission following re-induction with the original regimen; second or subsequent relapse, relapse after autologous hematopoietic stem cell transplantation (Auto-HSCT), or relapse after allogeneic hematopoietic stem cell transplantation (Allo-HSCT). (For patients with Philadelphia chromosome-positive \[Ph+\] disease, they must have received treatment with at least one tyrosine kinase inhibitor \[TKI\].);
* 3.Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
* 4.Bone marrow blast percentage of at least 5% (determined by morphology);
* 5.Expected life expectancy of at least 3 months;
* 6.Ability to sign the informed consent form and comply with protocol requirements; if the patient is unable to sign, their legal guardian or representative must sign on their behalf.
All of the following criteria must be met for acute B-cell lymphoblastic leukemia (B-ALL) with positive minimal residual disease (MRD) despite achieving complete remissio…
What they're measuring
1
Safety Analysis
Timeframe: From the signing of the informed consent form to 30 days after the last dose
2
Characteristics of Dose-Limiting Toxicity (DLT)
Timeframe: During the first cycle (each cycle lasts 42 days)