taniraleucel (CYNK-001)

P1, N=27, Terminated, Celularity Incorporated | N=94 --> 27 | Recruiting --> Terminated; Business reasons

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.

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.

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.

P1/2, N=0, Withdrawn, Celularity Incorporated | N=66 --> 0 | Recruiting --> Withdrawn

P1/2, N=66, Recruiting, Celularity Incorporated | Not yet recruiting --> Recruiting

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.

P1/2, N=66, Not yet recruiting, Celularity Incorporated

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.

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.

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.

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.

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.