Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0IWGEL |
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| Antibody Name | A anti-CD19 IgG1 mAb |
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| Antigen Name | CD19 |
Antigen Info | ||||
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
ABBV-319 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible participants include B-cell malignancy patients (WHO-confirmed, measurable disease) with lab values meeting protocol criteria; prior CD19-targeting therapy requires post-treatment biopsy. Exclusions: active CNS disease/lymphoma, uncontrolled infections, or ECOG ≥2.
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| Related Clinical Trial | |||||
| NCT Number | NCT05512390 | Clinical Status | PHASE1 | ||
| Clinical Description |
A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
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| Primary Endpoint |
The study evaluates ABBV-319 safety through DLT assessment (within 42 days) and tracks AEs (≤30 months). PK parameters (Cmax, Tmax, t½, AUC) and ADA incidence are monitored for ≤6 months to assess drug exposure and immunogenicity.
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| Other Endpoint |
Efficacy endpoints measure PR or better (≤6 months), DOR, and time to response (CR/PR). PFS (≤30 months) tracks progression from first treatment, while OS records time to death from any cause.
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References