Product Description
A-319 is a T-cell activating bispecific antibody (BsAb) designed to target CD19 and CD3 (anti-CD19, anti-CD3) and is under development for the treatment of patients with B cell malignancies including B-cell leukemia and B-cell lymphoma. A-319 activates T lymphocytes in a patient to kill CD19 expressing malignant B-cells. (Sourced from: https://www.businesswire.com/news/home/20181111005067/en/Generon-Receives-Investigative-New-Drug-IND-Approval-from-China-SFDA-for-A-319-to-Treat-Patients-with-B-Cell-Malignancies)
Mechanisms of Action: CD19 Inhibitor, CD3 Inhibitor
Novel Mechanism: No
Modality: Bispecific Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Generon Pharmaceutical Technology (Shanghai) Co., Ltd.
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 1: Acute Lymphoid Leukemia|B-Cell Leukemia|Lupus Erythematosus, Systemic|Lymphoma, B-Cell
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06400537 |
UHCT240243 | P1 |
Recruiting |
Lupus Erythematosus, Systemic |
2026-12-01 |
12% |
2025-09-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
CTR20210368 |
CTR20210368 | P1 |
Recruiting |
B-Cell Leukemia|Acute Lymphoid Leukemia |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
CTR20190205 |
CTR20190205 | P1 |
Recruiting |
Lymphoma, B-Cell |
None |
2025-04-29 |