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Allogenic NK cells infusion
Allogenic NK cells infusion is a Cell therapy Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 1 development. Also known as: cellular therapy.
Infused natural killer cells from donors recognize and eliminate target cells through innate immune mechanisms without prior sensitization.
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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 | Allogenic NK cells infusion |
|---|---|
| Also known as | cellular therapy |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Cell therapy |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Natural killer (NK) cells are innate immune cells that can recognize and kill abnormal cells, including cancer cells and virus-infected cells. Allogenic NK cells from healthy donors are infused into patients to enhance immune surveillance and tumor cell destruction without requiring HLA matching.
Approved indications
Common side effects
Key clinical trials
- Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma (PHASE1)
- Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS) (PHASE2)
- NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (PHASE2)
- Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) (PHASE1, PHASE2)
- CIML NK Cells With Venetoclax for AML (PHASE1)
- Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma (PHASE1, PHASE2)
- Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites (PHASE1, PHASE2)
- Natural Killer-cell Therapy for Acute Myeloid Leukemia (PHASE1, 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:
- Allogenic NK cells infusion CI brief — competitive landscape report
- Allogenic NK cells infusion updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about Allogenic NK cells infusion
What is Allogenic NK cells infusion?
How does Allogenic NK cells infusion work?
Who makes Allogenic NK cells infusion?
Is Allogenic NK cells infusion also known as anything else?
What drug class is Allogenic NK cells infusion in?
What development phase is Allogenic NK cells infusion in?
Related
- Drug class: All Cell therapy drugs
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
- Also known as: cellular therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing