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CAT-8015 immunotoxin
CAT-8015 immunotoxin is a Small molecule drug developed by Cambridge Antibody Technology. It is currently in Phase 1 development.
CAT-8015 immunotoxin is an immunotoxin therapy used to treat various blood cancers, including Leukemia, Hairy Cell Leukemia, Acute Lymphoblastic Leukemia (ALL), and Lymphoma. The exact mechanism of CAT-8015 is unknown, but it is known to be a product of Cambridge Antibody Technology, previously referred to as CAT-203.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | CAT-8015 immunotoxin |
|---|---|
| Sponsor | Cambridge Antibody Technology |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Oedema peripheral
- Fatigue
- Nausea
- Headache
- Pyrexia
- Hypoalbuminaemia
- Diarrhoea
- Alanine aminotransferase increased
- Hypocalcaemia
- Hypophosphataemia
- Constipation
- Aspartate aminotransferase increased
Key clinical trials
- Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (PHASE1)
- Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL) (PHASE1)
- An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
- Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (PHASE3)
- A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia (PHASE1)
- Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL) (PHASE1, PHASE2)
- CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma (PHASE1)
- A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CAT-8015 immunotoxin CI brief — competitive landscape report
- CAT-8015 immunotoxin updates RSS · CI watch RSS
- Cambridge Antibody Technology portfolio CI
Frequently asked questions about CAT-8015 immunotoxin
What is CAT-8015 immunotoxin?
Who makes CAT-8015 immunotoxin?
What development phase is CAT-8015 immunotoxin in?
What are the side effects of CAT-8015 immunotoxin?
Related
- Manufacturer: Cambridge Antibody Technology — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing