CD19 Targeted Therapies
9 drugsAbout CD19
CD19 is a cell surface protein expressed on B cells throughout their development. It plays a critical role in B cell receptor signaling and activation. Its consistent presence on B cells makes it a target for therapies aimed at depleting or modifying these cells.
Human genetic studies provide strong validation for CD19 as a therapeutic target (max score 0.84). Loss-of-function variants are associated with increased risk of immunodeficiency, common variable, 3 (score 0.84), suggesting activation may be beneficial.
CD19 is targeted by 4 FDA-approved drugs including MONJUVI, UPLIZNA, BLINCYTO, and ZYNLONTA. These drugs employ various modalities including biologics, bispecific antibodies, and ADCs, primarily for oncology indications.
CD19 Genetic Evidence Strong
CD19 has strong genetic support with a max score of 0.84 linked to immunodeficiency.
Strong genetic support suggests CD19-targeting therapies have a higher probability of clinical success.
💡 Why activation?
- • Loss-of-function variants increase disease risk (OR > 1) — restoring function may help
- • 100% directional consistency across 2 traits
- • Strong signal in immune system disease, hematologic disease, genetic, familial or congenital disease pathways
Cross-Disease Effects
Trade-off: LowDirection of Effect
100% alignedEvidence Across Diseases
7 totalGWAS and other genetic studies link CD19 to 7 diseases.
Loss-of-function causes disease; activation may help
Loss-of-function causes disease; activation may help
Understanding these scores
Association Score (0-1): Combines all evidence types (genetic, literature, drugs, animal models). Higher = more evidence linking target to disease. This is a ranking heuristic, not a confidence score.
L2G Score: Open Targets uses a machine learning model (Locus-to-Gene) to predict which gene is causal at each GWAS locus. L2G=0.5 means ~50% probability of being the causal gene. Only associations with L2G > 0.05 are included.
Odds Ratio (OR): From gene burden studies (UK Biobank, AstraZeneca PheWAS). Measures how loss-of-function variants affect disease risk. OR<1 = protective (inhibiting target may help), OR>1 = risk (losing function causes disease).
Beta (β): Effect size for continuous traits. β<0 = protective, β>0 = risk.
Clinical Translation (~1.8x): Based on Nelson et al. 2015: drug targets with genetic evidence have ~2x higher success rates in clinical trials. We estimate: Strong support (score ≥0.7) → ~1.8x, Moderate (0.3-0.7) → ~1.3x, Weak → baseline.
Colocalization (H4): Tests whether a GWAS signal and an eQTL/pQTL signal share the same causal variant. H4 is the posterior probability that both traits are associated AND share a causal variant. H4 > 0.8 = strong evidence that gene expression/protein levels drive disease risk. This links genetic variation → gene expression → disease, supporting the target-disease connection.
Top CD19 Drugs
Four companies have approved CD19-targeting drugs, including MORPHOSYS, VIELA BIO, Amgen and ADC Therapeutics.
The presence of four companies indicates a moderately competitive landscape with potential entry barriers.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| BLINCYTO | Amgen | 2014 | 1 |
| Yescarta | Gilead Sciences | 2017 | - |
| Kymriah | Novartis | 2017 | - |
| Tecartus | Gilead Sciences | 2020 | - |
| Breyanzi | Juno Therapeutics, Inc. a Bristol Myer-Squibb Company | 2021 | - |
| Aucatzyl | Autolus, Inc. | 2024 | - |
CD19 Drug Modality Landscape
Modalities
Routes of Administration
CD19 requires biologic approaches (gene therapy), likely due to its structure or location.
Explore novel modalities beyond biologics to differentiate from existing CD19 therapies.
📈 Modality Evolution
Bispecific antibodies pioneered CD19 targeting (2014), with adcs entering more recently (2021).
CD19 Clinical Trials 311 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on CD19. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 93 | 20 | 16 | 54 | 56% |
| Phase 2 | 176 | 37 | 23 | 115 | 62% |
| Phase 3 | 34 | 4 | 2 | 28 | 67% |
| Phase 4 | 8 | 1 | 1 | 6 | 50% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
5 Phase 3 trials testing approved CD19 drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting CD19. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
CD19 Drug Approval Timeline (2014 - 2024)
The first CD19-targeting drug was approved in 2014, with the most recent in 2021.
The approval timeline suggests continued interest in CD19, but potential market saturation.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 8 companies competing
- • Market share by company
Full Drug Portfolio
- • All 9 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 9-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 126 (24 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on CD19. A trial counts if an approved drug acting on CD19 is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.