Floatz Rating
B57/100
Confidence
Indicative
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Modality
Cell therapy
Development Phase
Phase 2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
56High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07256210CT.gov Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation | — | Recruiting | — | — | — |
NCT06783478CT.gov NK Cell Infusion for Remission Consolidation in AML: A Phase II Trial | — | Not Yet Recruiting | — | — | — |
NCT05319249CT.gov Natural Killer Cell Immunotherapy in Combination With PARP-inhibition in Acute Myeloid Leukemia | — | Not Yet Recruiting | — | — | — |
NCT05834244CT.gov A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML) | — | Recruiting | — | — | — |
NCT05400122CT.gov Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer | — | Suspended | — | — | — |
NCT05333705CT.gov Donor Immune Cell Therapy for Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT04221971CT.gov NK Cell Infusion for Patients With Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT04166929CT.gov Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS | — | Terminated | — | — | — |
NCT02890758CT.gov Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803 | — | Completed | — | — | — |
NCT02809092CT.gov Interleukin-21 (IL-21)- Expanded Natural Killer Cells for Induction of Acute Myeloid Leukemia | — | Unknown | — | — | — |
Show 12 more trialsShow fewer
NCT02763475CT.gov NK Cells as Consolidation Therapy of Acute Myeloid Leukemia in Children/Adolescents | — | Completed | — | — | — |
NCT02229266CT.gov Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML | — | Terminated | — | — | — |
NCT02477787CT.gov Randomized Study of Haploidentical Hct and Subsequent Donor nk Cell Infusion in High-risk AML and MDS | — | Terminated | — | — | — |
NCT01639456CT.gov CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission | — | Withdrawn | — | — | — |
NCT01795378CT.gov Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation | — | Completed | — | — | — |
NCT01478074CT.gov ALT-801-activated Natural Killer Cells After FLAG Induction for Acute Myeloid Leukemia | — | Withdrawn | — | — | — |
NCT01370213CT.gov NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases | — | Completed | — | — | — |
NCT01106950CT.gov Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML) | — | Terminated | — | — | — |
NCT00799799CT.gov Adoptive Immunotherapy of High Risk Acute Myeloblastic Leukemia Patients Using Haploidentical Kir Ligand-mismatched Natural Killer Cells | — | Unknown | — | — | — |
NCT00187096CT.gov Natural Killer (NK) Cell Transplantation for AML | — | Completed | — | — | — |
NCT00303667CT.gov Donor Natural Killer Cells and Aldesleukin in Treating Patients w/High Risk AML Undergoing Donor Stem Cell Transplant | — | Completed | — | — | — |
NCT01220544CT.gov Haploidentical Transplantation With Early Adoptive Transfer of CD56+CD3- NK Cells | — | Unknown | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nadravaleucel (this asset) | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | P2 | B · 57 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Nadravaleucel
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Central Nervous System Neoplasm | — | P2 | B · 61 |
| Non-Hodgkin Lymphoma | — | P2 | B · 59 |
| Myelodysplastic Syndrome | — | P2 | B · 58 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Nadravaleucel in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/nadravaleucel-acute-myeloid-leukemia-125045
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