This is a single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites .
The study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity .
The study consists of two phases:
Phase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a "3+3" design with three increasing dose levels.
Phase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D.
Participants will receive the study treatment once weekly for 4 weeks.
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Single group
SK-NK Cell Injection
Biological/VaccineAdministered via intraperitoneal perfusion. Phase I involves a "3+3" dose escalation with three cohorts: 3x10\^8, 6x10\^8, and 9x10\^8 cells. Phase II uses the Recommended Phase 2 Dose (RP2D). The treatment schedule consists of one infusion weekly for 4 weeks (Days 1, 8, 15, and 22). The product is characterized by high purity (\>99%) and high expression of activation markers.
Incidence of Adverse Events and Dose-Limiting Toxicities
Number of participants experiencing TEAEs and DLTs. Safety is evaluated using NCI CTCAE v5.0 and ASTCT consensus for CRS.
RP2D
To determine the optimal dose for the Phase II expansion phase based on the evaluation of DLTs and the overall safety profile observed in the dose-escalation cohorts.
Ascites Response Rate
Defined as the proportion of participants who require no paracentesis (abdominal drainage) for at least 4 weeks and whose ascites volume (measured by ultrasound as average depth x 10 x abdominal circumference) is controlled at Day 29.
Objective Response Rate (ORR)
Defined as the percentage of participants who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) after intraperitoneal perfusion.
Ascites Symptom Improvement Rate
Defined as the proportion of participants whose malignant ascites symptom scale score decreases by ≥30% compared to baseline.
Duration of Ascites Relief (DoR)
Defined as the time from the first documentation of objective response (CR or PR) to the first documented disease progression or death from any cause.
Changes in Cytokine Levels in Peripheral Blood and Ascites
Evaluation of levels of IL-2, TNF-a, and IFN-y (measured in pg/mL) using flow cytometry.
Changes in Immune Cell Subsets
Evaluation of the percentage of Tregs, Macrophages, and MDSCs relative to total CD45+ cells.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Cells First Biotechnology (Beijing) Co., Ltd
Collaborator
