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AC*4-T*4
AC*4-T*4 is a Small molecule drug developed by Zhejiang Cancer Hospital. It is currently in Phase 3 development for Cancer (specific indication not publicly detailed). Also known as: CTX+Anthracyclines, Docetaxel.
AC*4-T*4 is an engineered T cell therapy designed to target and eliminate cancer cells expressing specific tumor antigens.
AC*4-T*4 is a protein modality that has been studied in clinical trials for various breast cancer conditions, including breast adenocarcinoma, estrogen receptor-negative breast cancer, and estrogen receptor-positive breast cancer. It has been used in combination with chemotherapy agents such as doxorubicin, cyclophosphamide, and paclitaxel in trials like NCT02957968.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | AC*4-T*4 |
|---|---|
| Also known as | CTX+Anthracyclines, Docetaxel |
| Sponsor | Zhejiang Cancer Hospital |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This appears to be a cell-based immunotherapy, likely involving autologous or allogeneic T cells engineered to recognize and attack malignant cells. The nomenclature suggests a multi-component cellular construct, possibly combining multiple targeting or functional domains to enhance anti-tumor activity and persistence.
Approved indications
- Cancer (specific indication not publicly detailed)
Common side effects
- Cytokine release syndrome
- Immune-related adverse events
Key clinical trials
- Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma (PHASE1)
- Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting (PHASE2)
- Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome (PHASE2)
- Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) (PHASE1, PHASE2)
- FMD and Neoadjuvant Chemo-immunotherapy in TNBC (PHASE2)
- Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer (PHASE2)
- Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer (PHASE2)
- A Phase II Exploratory Study of Iparomlimab and Tuvonralimab Combined With Chemotherapy in Neoadjuvant Treatment of HR+/HER2- Breast Cancer Patients (PHASE2)
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:
- AC*4-T*4 CI brief — competitive landscape report
- AC*4-T*4 updates RSS · CI watch RSS
- Zhejiang Cancer Hospital portfolio CI
Frequently asked questions about AC*4-T*4
What is AC*4-T*4?
How does AC*4-T*4 work?
What is AC*4-T*4 used for?
Who makes AC*4-T*4?
Is AC*4-T*4 also known as anything else?
What development phase is AC*4-T*4 in?
What are the side effects of AC*4-T*4?
Related
- Manufacturer: Zhejiang Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cancer (specific indication not publicly detailed)
- Also known as: CTX+Anthracyclines, Docetaxel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing