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 (Jun 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
Treatments studied
Other
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: ...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06730009 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational therapy, immune cell therapy, anti-neoplastic medications disqualifies patients from enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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