Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319)
ConditionAcute Lymphocytic Leukemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanxi Bethune Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
1.Central nervous system (CNS) leukemia (confirmed by cerebrospinal fluid [CSF] analysis) or acute lymphoblastic leukemia (ALL) with clinically relevant CNS involvement;
2.Burkitt's leukemia, testicular infiltration in acute lymphoblastic leukemia (ALL);
3.A history of malignancy other than ALL within 5 years prior to the initiation of protocol-specific treatment. Exceptions include: malignancies treated with curative intent, with no known active disease for 5 years before enrollment, and deemed by the treating physician to have a low recurrence risk; non-melanoma skin cancer or lentigo maligna that has been adequately treated with no evidence of recurrence; carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrence; ductal carcinoma in situ of the breast that has been adequately treated with no evidence of recurrence;and prostatic intraepithelial neoplasia with no evidence of prostate cancer;
4.Patients with grade 2-4 acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or those with chronic GVHD requiring immunosuppressive therapy;
Trial design
Treatments tested in this trial
- Treatment with A319
Treatment groups
18 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov