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DRUG:

taniraleucel (CYNK-001)

i
Other names: CYNK-001
Company:
Celularity, United Therapeutics Corp
Drug class:
NK cell stimulant
Related drugs:
1year
Conditioning Impacts on Regulatory T-Cells (Tregs) in the Microenvironment of AML: Observations from the Phase 1 Cynk-001-AML-001 Trial (ASH 2023)
CYNK-001 proliferation and persistence was not enhanced with rhIL-2 infusion. Based on these data, rIL-2 was excluded from subsequent cohorts in this study.
P1 data
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CD8 (cluster of differentiation 8) • CD34 (CD34 molecule) • NCAM1 (Neural cell adhesion molecule 1)
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taniraleucel (CYNK-001)
1year
Results of Cynk-001-AML-001: A Phase I Multi-Dose Study Evaluating the Safety, Tolerability, and Persistence of Cynk-001 in Adults with De Novo or Secondary Acute Myeloid Leukemia in Morphologic Complete Remission with Minimal Residual Disease or Relapsed/Refractory AML (ASH 2023)
Patients in cohorts 1-3 underwent standard lymphodepletion with fludarabine (25 mg/m2/day) and cyclophosphamide (300 mg/m2/day) on days -5, -4 and -3. This trial yielded important insights into the optimal approach to lymphodepletion and the potential clinical efficacy of allogeneic NK cells in R/R AML. Based on these results, this trial is now closed to further enrollment and future development activities will focus on next generation NK cell therapies edited to optimize persistence and efficacy and limit the requirement for enhanced lymphodepletion.
Clinical • P1 data • Minimal residual disease
|
CD34 (CD34 molecule) • IL2 (Interleukin 2) • NCAM1 (Neural cell adhesion molecule 1)
|
cyclophosphamide • fludarabine IV • taniraleucel (CYNK-001)
over1year
Developing CYNK-001-derived exosomes to deliver TGF-β siRNA for GBM immunotherapy enhancement (AACR 2023)
Our results demonstrated anti-tumor activity of CYNK-Exo against GBM cells; efficient TGF-β knockdown in GBM cells by siCYNK-Exo; and synergistic anti-tumor activity ofTGF-β siCYNK-Exo in combination with CYNK-001 against GBM cells. Our data support a potential combination therapy using CYNK-001 and TGF-β siCYNK-Exo for GBM treatment.
IO biomarker
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IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD34 (CD34 molecule) • NCAM1 (Neural cell adhesion molecule 1) • CD9 (CD9 Molecule) • CSF2 (Colony stimulating factor 2) • GZMB (Granzyme B) • TGFB1 (Transforming Growth Factor Beta 1) • GZMA (Granzyme A) • CD81 (CD81 Molecule)
|
taniraleucel (CYNK-001)
almost2years
Enrollment change • Trial withdrawal • Combination therapy
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH wild-type
|
cyclophosphamide • taniraleucel (CYNK-001)
over2years
Enrollment open • Combination therapy
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH wild-type
|
cyclophosphamide • taniraleucel (CYNK-001)
over2years
A phase I/IIa, open-label, multicenter, non-randomized clinical trial to assess the safety and efficacy of CYNK-001 in combination with recombinant human interleukin 2 in adults with recurrent resection eligible IDH1 wild-type glioblastoma (GBM). (ASCO 2022)
Screening MRI scans for inclusion are performed within 14 days prior to Day -5 lymphodepletion with Cyclophosphamide 900mg/m2 and fludarabine 30mg/m2 plus mesna. Approximately 66 patients are planned for this Phase I/IIa study. Approximately 66 patients are planned for this Phase I/IIa study.
Clinical • P1/2 data • Combination therapy
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CD34 (CD34 molecule) • IL2 (Interleukin 2) • NCAM1 (Neural cell adhesion molecule 1)
|
IDH wild-type
|
cyclophosphamide • fludarabine IV • mesna • taniraleucel (CYNK-001)
almost3years
New P1/2 trial • Combination therapy
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH wild-type
|
taniraleucel (CYNK-001)
almost4years
[VIRTUAL] A Phase 1 Multi-Dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK‑001) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD) (NCT04310592) (TCT-ASTCT-CIBMTR 2021)
In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.
Clinical • P1 data
|
CD34 (CD34 molecule)
|
Venclexta (venetoclax) • azacitidine • fludarabine IV • taniraleucel (CYNK-001) • PNK-007
almost4years
[VIRTUAL] A Phase 1 Multi-Dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK‑001) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD) (NCT04310592) (TCT-ASTCT-CIBMTR 2021)
In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.
Clinical • P1 data
|
CD34 (CD34 molecule)
|
Venclexta (venetoclax) • azacitidine • fludarabine IV • taniraleucel (CYNK-001) • PNK-007
almost4years
[VIRTUAL] A Phase 1 Multi-Dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK‑001) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD) (NCT04310592) (TCT-ASTCT-CIBMTR 2021)
In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.
Clinical • P1 data
|
CD34 (CD34 molecule)
|
Venclexta (venetoclax) • azacitidine • fludarabine IV • taniraleucel (CYNK-001) • PNK-007
almost4years
[VIRTUAL] A Phase 1 Multi-Dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK‑001) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD) (NCT04310592) (TCT-ASTCT-CIBMTR 2021)
In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.
Clinical • P1 data
|
CD34 (CD34 molecule)
|
Venclexta (venetoclax) • azacitidine • fludarabine IV • taniraleucel (CYNK-001) • PNK-007
almost4years
[VIRTUAL] A Phase 1 Multi-Dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK‑001) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD) (NCT04310592) (TCT-ASTCT-CIBMTR 2021)
In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.
Clinical • P1 data
|
CD34 (CD34 molecule)
|
Venclexta (venetoclax) • azacitidine • fludarabine IV • taniraleucel (CYNK-001) • PNK-007