Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites

NCT07435701 | Recruiting Phase 1 DMC

• 1 other identifier: NCC5843
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Neoplasms Malignant; Ascites

Keywords

SK-NK Cell Injection; Natural Killer Cells; NK Cell Therapy; Intraperitoneal Perfusion; Adoptive Immunotherapy; Immunotherapy; Massive Ascites

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline up to 28 days post-infusion for DLT; safety follow-up through study completion (approx. 1 year)

• 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.

  Up to approximately 28 days after the first dose of the last participant in the dose-escalation phase.

Secondary Outcomes (7)

• Ascites Response Rate

  At Day 29 (±3 days) post-treatment initiation

• Objective Response Rate (ORR)

  Assessed periodically up to approximately 1 year

• Ascites Symptom Improvement Rate

  Assessed periodically up to approximately 1 year

• Duration of Ascites Relief (DoR)

  From date of first response until progression or death, assessed up to approx. 1 year

• 1-Year Overall Survival (OS) Rate

  1 year post-treatment initiation

Other Outcomes (2)

• Changes in Cytokine Levels in Peripheral Blood and Ascites

  At Baseline, Day 8, Day 15, Day 22, and End of Treatment (Day 29).

• Changes in Immune Cell Subsets

  At Baseline, Day 8, Day 15, Day 22, and End of Treatment (Day 29).

Study Arms (1)

SK-NK Cell Injection

EXPERIMENTAL

Participants receive SK-NK Cell Injection via intraperitoneal perfusion. Phase I follows a "3+3" dose-escalation design with three cohorts (3\*10\^8, 6\*10\^8, and 9\*10\^8 cells). Phase II operates at the Recommended Phase 2 Dose (RP2D). Treatment is administered once weekly for 4 weeks (Days 1, 8, 15, and 22).

Biological: SK-NK Cell Injection

Interventions

SK-NK Cell Injection BIOLOGICAL

Administered 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.

Also known as: Super Kill-NK Cell Injection, Allogeneic NK Cell Injection

SK-NK Cell Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the written Informed Consent Form (ICF) and be able to comply with study procedures and follow-up.
• Female, aged 18 to 75 years. ECOG performance status of 0 to 2. Histologically or cytologically confirmed advanced ovarian cancer. Participants must have failed at least two lines of standard therapy (disease progression or intolerance), have no standard therapy available, or be unable to receive standard therapy for other reasons .
• Complicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT.
• Expected survival time ≥ 3 months.
• Adequate organ function (no blood transfusion, cell growth factors, etc., within 14 days prior to enrollment), defined as:
• Neutrophils (ANC) ≥ 1.0×10\^9/L Platelets (PLT) ≥ 80×10\^9/L Hemoglobin (Hb) ≥ 80 g/L Total Bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome or liver metastasis) ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis is present) INR ≤ 1.5×ULN and APTT ≤ 1.5×ULN (unless on anticoagulant therapy) Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula) Toxicities from prior therapies must have recovered to ≤ Grade 1 (except for alopecia and ≤ Grade 2 neurotoxicity caused by chemotherapy) .

You may not qualify if:

• Prior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor therapy (including chemotherapy, targeted therapy, etc.) within 3 weeks prior to intraperitoneal perfusion.
• Receipt of Traditional Chinese Medicine (herbal) with anti-tumor indications within 3 weeks prior to intraperitoneal perfusion.
• Receipt of systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 2 weeks prior to intraperitoneal perfusion (inhaled, topical, or physiologic replacement doses are allowed).
• Major surgery within 4 weeks prior to screening or planned major surgery during the study period.
• History of other malignancies within 5 years (except for cured local tumors with low risk of recurrence, such as non-melanoma skin cancer).
• History of active or suspected autoimmune or inflammatory disease. History of organ transplantation or hematopoietic stem cell transplantation.
• Presence of active infection, including:
• Active Hepatitis B (HBsAg positive and HBV-DNA \> 1000 copies/mL) Active Hepatitis C (HCV antibody positive and HCV-RNA detected) Systemic active infection requiring antibiotic treatment Congenital or acquired immunodeficiency (e.g., HIV infection) Vaccination with live or attenuated vaccines within 4 weeks prior to intraperitoneal perfusion.
• Severe cardiovascular diseases, including:
• Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg) History of hypertensive crisis or hypertensive encephalopathy Cardiovascular accident, TIA, myocardial infarction, unstable angina, or significant vascular disease within 6 months NYHA Class ≥ II heart failure or LVEF \< 50% Severe arrhythmia uncontrolled by medication (QTc ≥ 450 ms for males, ≥ 470 ms for females), or congenital Long QT syndrome Severe respiratory disease (e.g., history of severe interstitial lung disease, severe COPD), FEV1 \< 2L, or DLCO \< 40%.
• History of clear neurological or psychiatric disorders, including epilepsy or dementia.
• Other conditions considered unsuitable for the study by the investigator (e.g., prior Grade ≥ 3 adverse events from immunotherapy).

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Cells First Biotechnology (Beijing) Co., Ltd: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ning Li, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, MD

CONTACT

8610-87787211; liningnci@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Phase I utilizes a standard "3+3" dose-escalation design with three dose levels (3x10\^8, 6x10\^8, 9x10\^8 cells). Phase II is a dose-expansion phase at the Recommended Phase 2 Dose (RP2D) to further evaluate efficacy and safety.

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: January 5, 2026
• Primary Completion: January 23, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data requests should be submitted to the corresponding author via email. Requesting researchers must provide a methodologically sound proposal and sign a data access agreement.

Locations

CN (1)