CYNK-101

P1/2, N=52, Active, not recruiting, Celularity Incorporated | Recruiting --> Active, not recruiting

Patients complete a disease assessment and then proceed to a lymphodepletion regimen of cyclophosphamide 900 mg/m2 and fludarabine 30 mg/m2 with MESNA for 3 days...Approximately 52 patients are planned for this Phase I/IIa study. Clinical trial information: NCT05207722.

Conclusions Our results demonstrate that CYNK-101 has enhanced Avelumab-mediated ADCC activity against PD-L1 + tumor cell lines, such as lung, breast, and bladder cancers. Further development of the combinational therapy for PD-L1 + solid tumor indications is warranted.

P1/2, N=52, Recruiting, Celularity Incorporated | Not yet recruiting --> Recruiting

P1/2, N=52, Not yet recruiting, Celularity Incorporated

Luciferase expressing Daudi cells (3×10 6 ) were intravenously (IV) injected on Day 0 three days after preconditioning with a myeloablative dose of busulfan to allow for better tumor cell engraftment...Furthermore, CYNK-101 in combination with daratumumab demonstrated an enhanced survival benefit with a median survival of 35 days versus a median survival of 28 days for the vehicle treated group (p<0.005). In summary, our results demonstrate enhanced in vitro and in vivo ADCC activities of CYNK-101 in combination with daratumumab against CD38 + hematological tumors and warrant further development of this combination therapy for these cancers.

CYNK-101 was generated from multiple placental CD34+ donors (n=7) with >90% CD56+CD3-and 74.1 ± 5.6% CD16 expression. While 4h PMAi treatment resulted in >89% CD16 cleavage on non-transduced NK cells, <11% cleavage from CYNK-101 demonstrated CD16 shedding resistance. At an effector to target (E:T) ratio of 1:1, CYNK-101 (n=7) showed enhanced lysis of NCI-N87 cells in the presence of Trastuzumab compared to IgG control, 59.6 ± 13.7% vs.