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NCT02781467
A Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (rhIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid Leukemia (AML)
Phase 1 trial testing PNK-007 in Leukemia, Myeloid, Acute in 10 participants. Terminated before completion.
7 December 2017
Quick facts
| Lead sponsor | Celularity Incorporated |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 11 July 2016 |
| Primary completion | 7 December 2017 |
| Estimated completion | 7 December 2017 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- PNK-007 — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Human recombinant Interleukin-2 (rhIL-2) — full drug profile →
Conditions studied
- Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →
Sponsor
Celularity Incorporated — full company profile →
Who can join
Adults 18 to 70, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will find the highest acceptable treatment dose of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with relapsed and/or refractory acute myeloid leukemia. The NK cells will be given with chemotherapy and Recombinant human interleukin 2 (rhIL-2) to help the NK cells expand in the body. The safety of this treatment will be studied and researchers want to learn if NK cells will help in treating the AML.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5 -
Cord-Blood Natural Killer Cell-Based Immunotherapy for Cancer.
Zhao X, Cai L, Hu Y, Wang H. · · 2020 · cited 35× · PMID 33193399 · DOI 10.3389/fimmu.2020.584099 -
Cells to prevent/treat relapse following allogeneic stem cell transplantation.
Dietz AC, Wayne AS. · · 2017 · cited 10× · PMID 29222325 · DOI 10.1182/asheducation-2017.1.708 -
NK cell-based immunotherapy strategies for myeloid leukemia.
Zhang L, Zhao Y, Dong Y, Jiang X. · · 2025 · cited 4× · PMID 40726987 · DOI 10.3389/fimmu.2025.1621885 -
A systematic review of the last two decades of NK cell-based clinical trials: state of the art of AML therapy.
Bakhtiyaridovvombaygi M, Kheyrandish S, Safdari SM, Eskandrian S, et al · · 2025 · cited 1× · PMID 41029201 · DOI 10.1186/s12885-025-14837-y
Verify or expand the search:
- PubMed search for NCT02781467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PNK-007
Trials testing the same drug.
- NCT02955550 — A Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion With or Without Sub · Phase 1 · completed
Other recruiting trials for Leukemia, Myeloid, Acute
Currently open trials in the same condition.
- NCT06852222 — A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leuke · Phase 3 · recruiting
- NCT06651229 — A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
- NCT06618001 — A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
- NCT06643962 — Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearan · NA · recruiting
- NCT06382168 — DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting
Other Celularity Incorporated trials
Trials by the same sponsor.
- NCT05207722 — CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic · Phase 1, PHASE2 · terminated
- NCT04489420 — Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM · Phase 1 · terminated
- NCT04365101 — Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19 · Phase 1, PHASE2 · unknown
- NCT04309084 — Natural Killer Cell (CYNK-001) Infusions in Adults With Multiple Myeloma · Phase 1 · unknown
- NCT04310592 — Natural Killer Cell (CYNK-001) Infusions in Adults with AML · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02781467 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Celularity Incorporated
- Last refreshed: 22 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02781467.
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