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NCT06201247
Off-the-shelf CD123 CAR-NK for R/R AML
EARLY_PHASE1 trial testing JD123 injection in Acute Myeloid Leukemia, in Relapse in 12 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 30 December 2023 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- JD123 injection — full drug profile →
Conditions studied
- Acute Myeloid Leukemia, in Relapse — all drugs for Acute Myeloid Leukemia, in Relapse →
- Acute Myeloid Leukemia Refractory — all drugs for Acute Myeloid Leukemia Refractory →
Sponsor
Peking University People's Hospital
Who can join
18 and older, any sex, with Acute Myeloid Leukemia, in Relapse or Acute Myeloid Leukemia Refractory. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comprehensive snapshots of natural killer cells functions, signaling, molecular mechanisms and clinical utilization.
Chen S, Zhu H, Jounaidi Y. · · 2024 · cited 106× · PMID 39511139 · DOI 10.1038/s41392-024-02005-w -
The clinical landscape of CAR NK cells.
Jørgensen LV, Christensen EB, Barnkob MB, Barington T. · · 2025 · cited 61× · PMID 40149002 · DOI 10.1186/s40164-025-00633-8 -
Innate immune cells in tumor microenvironment: A new frontier in cancer immunotherapy.
Li C, Yu X, Han X, Lian C, et al · · 2024 · cited 31× · PMID 39280627 · DOI 10.1016/j.isci.2024.110750 -
The development and application of chimeric antigen receptor natural killer (CAR-NK) cells for cancer therapy: current state, challenges and emerging therapeutic advances.
Yao P, Liu YG, Huang G, Hao L, et al · · 2024 · cited 19× · PMID 39633491 · DOI 10.1186/s40164-024-00583-7 -
Natural killer cell-based cancer immunotherapy: from basics to clinical trials.
Shi Y, Hao D, Qian H, Tao Z. · · 2024 · cited 17× · PMID 39415291 · DOI 10.1186/s40164-024-00561-z -
The basic biology of NK cells and its application in tumor immunotherapy.
Jiang P, Jing S, Sheng G, Jia F. · · 2024 · cited 17× · PMID 39221244 · DOI 10.3389/fimmu.2024.1420205 -
Revolutionising Cancer Immunotherapy: Advancements and Prospects in Non-Viral CAR-NK Cell Engineering.
Zhou Z, Chen Y, Ba Y, Xu H, et al · · 2025 · cited 16× · PMID 39731215 · DOI 10.1111/cpr.13791 -
Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
Verify or expand the search:
- PubMed search for NCT06201247
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Myeloid Leukemia, in Relapse
Currently open trials in the same condition.
- NCT04716452 — Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
- NCT06372717 — A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS · Phase 1 · recruiting
- NCT06125652 — Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML) · Phase 1, PHASE2 · recruiting
- NCT06017258 — A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia · Phase 1 · recruiting
- NCT05597306 — Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
Other Peking University People's Hospital trials
Trials by the same sponsor.
- NCT07535645 — Baricitinib for Post-HSCT Persistent Thrombocytopenia · Phase 1, PHASE2 · not yet recruiting
- NCT07516002 — Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency · not yet recruiting
- NCT07294339 — A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positiv · NA · not yet recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
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 NCT06201247 (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 Peking University People's Hospital
- Last refreshed: 11 March 2025
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/NCT06201247.
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