Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0LFZFX
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| ADC Name |
ABBV-319
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| Synonyms |
ABBV-319
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| Organization |
AbbVie (Top20 MNC) (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Anti-CD19 IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
B-lymphocyte antigen CD19 (CD19)
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Antigen Info | ||||
| Payload Name |
Glucocorticoid receptor modulator
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Payload Info | ||||
| Therapeutic Target |
Glucocorticoid receptor (NR3C1)
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Target Info | ||||
| Linker Name |
MP-Ala-Ala
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Chronic lymphocytic leukemia |
1 Trials
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| Diffuse large b-cell lymphoma |
1 Trials
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| Follicular lymphoma |
1 Trials
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| Lupus erythematosus |
1 Trials
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| Sj?gren syndrome |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
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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| Administration Dosage |
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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 | ||||
| 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