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DRUG:

WU-NK-101

i
Other names: WU-NK-101, cytokine-induced memory-like NK cells, HCW9201 based cell therapy, W-NK1
Associations
Company:
HCW Biologics, Wugen
Drug class:
NK cell stimulant
Related drugs:
Associations
2ms
Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant (clinicaltrials.gov)
P1/2, N=62, Completed, Washington University School of Medicine | Recruiting --> Completed | N=110 --> 62 | Trial completion date: Oct 2028 --> Jun 2025 | Trial primary completion date: Oct 2028 --> Jun 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
cytarabine • cyclophosphamide • WU-NK-101
3ms
WUN101-01: A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1, N=9, Completed, Wugen, Inc. | Trial completion date: Jan 2025 --> Oct 2024 | Active, not recruiting --> Completed
Trial completion • Trial completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
WU-NK-101
7ms
Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant (clinicaltrials.gov)
P1/2, N=110, Recruiting, Washington University School of Medicine | Active, not recruiting --> Recruiting | N=62 --> 110 | Trial completion date: Nov 2025 --> Oct 2028 | Trial primary completion date: Nov 2025 --> Oct 2028
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
|
cytarabine • cyclophosphamide • WU-NK-101
7ms
Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant (clinicaltrials.gov)
P1/2, N=62, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | N=110 --> 62 | Trial completion date: Oct 2028 --> Nov 2025 | Trial primary completion date: Oct 2028 --> Nov 2025
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
cytarabine • cyclophosphamide • WU-NK-101
8ms
A Phase 1b Study of WU-NK-101 in Combination With Cetuximab (clinicaltrials.gov)
P1, N=30, Active, not recruiting, Wugen, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • EGFR expression • RAS mutation
|
Erbitux (cetuximab) • WU-NK-101
1year
WUN101-01: A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1, N=9, Active, not recruiting, Wugen, Inc. | Trial completion date: Dec 2025 --> Jan 2025
Trial completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
WU-NK-101
over1year
WUN101-01: A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1, N=9, Active, not recruiting, Wugen, Inc. | Recruiting --> Active, not recruiting | N=24 --> 9
Enrollment closed • Enrollment change
|
BCL2 (B-cell CLL/lymphoma 2)
|
WU-NK-101
over1year
WUN101-01: A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
P1, N=24, Recruiting, Wugen, Inc. | Trial primary completion date: Apr 2024 --> Dec 2024
Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
WU-NK-101
over1year
A "Prime and Expand" strategy using the multifunctional fusion proteins to generate memory-like NK cells for cell therapy. (PubMed, Cancer Immunol Immunother)
The resulting "Prime and Expand" ML NK cells exhibited elevated metabolic capacity, stable epigenetic IFNG promoter demethylation, enhanced antitumor activity in vitro and in vivo, and superior persistence in NSG mice. Thus, the "Prime and Expand" strategy represents a simple feeder cell-free approach to streamline manufacturing of clinical-grade ML NK cells to support multidose and off-the-shelf ACT.
Journal
|
IFNG (Interferon, gamma) • IL18 (Interleukin 18) • IL15 (Interleukin 15) • IL21 (Interleukin 21) • IL7 (Interleukin 7)
|
WU-NK-101
over1year
A Phase 1b Study of WU-NK-101 in Combination With Cetuximab (clinicaltrials.gov)
P1, N=30, Recruiting, Wugen, Inc. | Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2025 --> Sep 2025
Enrollment open • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
|
Erbitux (cetuximab) • WU-NK-101
2years
A Phase 1b Study of WU-NK-101 in Combination With Cetuximab (clinicaltrials.gov)
P1, N=30, Not yet recruiting, Wugen, Inc. | Phase classification: P1b --> P1 | Initiation date: Nov 2023 --> Jun 2024
Phase classification • Trial initiation date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • EGFR expression • RAS mutation
|
Erbitux (cetuximab) • WU-NK-101
2years
Adoptively Infused Memory-like Natural Killer Cells Impact Adaptive Immune Responses in Patients with Acute Myeloid Leukemia (ASH 2023)
Patients were lymphodepleted with fludarabine and cyclophosphamide...Multi-modal analyses of WU-NK-101 highlight unique transcriptional and functional states, which could underpin in vivo potency and persistence. WU-NK-101 are currently being evaluated in a phase 1 study of R/R AML (#NCT05470140).
Clinical • PARP Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • CD276 (CD276 Molecule) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD34 (CD34 molecule) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • NCAM1 (Neural cell adhesion molecule 1) • STING (stimulator of interferon response cGAMP interactor 1) • IL18 (Interleukin 18) • CD7 (CD7 Molecule) • IL15 (Interleukin 15) • TRB (T Cell Receptor Beta Locus)
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nCounter® PanCancer IO 360™ Panel • Oncomine™ TCR Pan-Clonality Assay
|
cyclophosphamide • fludarabine IV • WU-NK-101