OncoMatch/Clinical Trials/NCT06730009
Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients
Is NCT06730009 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including SLOG + Allogeneic NK cell and SLOG chemotherapy for pancreatic carcinoma stage ii.
Treatment: SLOG + Allogeneic NK cell · SLOG chemotherapy — This is a phase I/II study which intends to characterize the safety, tolerability, and preliminary efficacy of Allogeneic Magicell-NK infusion in PDA or cholangiocarcinoma patients after surgery. Subjects will receive a total of 6 intravenous (IV) infusions of the IP on the 11th day of each chemotherapy cycle. A total of 6 cycles of IP infusions are planned. The phase I part of the study is a first-in-human phase I trial of Allogeneic Magicell-NK and is therefore designed in an open-label, dose-escalation manner. A standard 3+3 design will be employed to assess the safety profile of Allogeneic Magicell-NK and to determine the MTD/MFD. Two dose cohorts are planned: the starting dose is 10 × 10\^8 cells (Cohort 1), and escalates to 20 × 10\^8 cells (Cohort 2). The phase II part of the study is designed as an open-label, two-arm, randomized clinical trial comparing the combination of SLOG and Allogeneic Magicell-NK with SLOG alone when used as adjuvant therapy following resection for PDA or Cholangiocarcinoma. Approximately 30 subjects will be randomized at a 2:1 ratio between the two arms: Arm 1: SLOG and Allogeneic Magicell-NK (20 subjects); Arm 2: SLOG alone (10 subjects). Subjects will then receive 12 weeks of SLOG chemotherapy with or without Allogeneic Magicell-NK infusion.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Cholangiocarcinoma
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — curative resection within 12 weeks prior to screening
Received curative resection within 12 weeks prior to screening visit
Cannot have received: investigational therapy
Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit
Cannot have received: immune cell therapy
Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit
Cannot have received: anti-neoplastic medications
Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit
Lab requirements
Blood counts
WBC ≥ 3,000 cells/mm3; ANC ≥ 1,500 cells/mm3; Platelets ≥ 100,000 counts/mm3; Hemoglobin ≥ 9 g/dL; INR of prothrombin time within normal range
Kidney function
Serum creatinine ≤ 1.5× ULN; BUN ≤ 1.5× ULN
Liver function
Total bilirubin ≤ 1.5× ULN; ALT and AST ≤ 2.5× ULN; ALP ≤ 5× ULN; Albumin ≥ 3.0 g/dL
Subject with adequate hematology function at Visit 1: ... Subject with adequate hepatic and renal function at Visit 1: ...
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