Actively Recruiting
Umbilical Cord Blood NK Cell Therapy for High-Risk Pediatric Soft Tissue Sarcoma: Efficacy and Safety Study
Led by Sun Yat-sen University · Updated on 2025-02-27
40
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label, non-blind, phase I/II clinical trial evaluating the safety and efficacy of umbilical cord blood natural killer (NK) cell in children with high-risk and relapsed/refractory soft tissue sarcoma (STS). Objective: Assess the safety and efficacy of NK cell in high-risk and relapsed/refractory STS patients. Observe the pharmacokinetics and pharmacodynamics of NK cells in these patients. Study Design: Single-arm, open-label, non-blind design. 40 patients with high-risk and relapsed/refractory STS will receive the NK cell combined with other treatment . The treatment regimen involves 8 doses of NK cells injected at specific time points over 3 months, followed by a 3-year follow-up period.
CONDITIONS
Official Title
Umbilical Cord Blood NK Cell Therapy for High-Risk Pediatric Soft Tissue Sarcoma: Efficacy and Safety Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or younger, any gender.
- Karnofsky score (for age 16 or older) or Lansky score (under 16) of at least 50.
- Diagnosed with high-risk and relapsed/refractory pediatric soft tissue sarcoma with prior comprehensive treatment.
- Estimated survival time of at least 12 weeks.
- Fully recovered from acute toxicities of previous chemotherapy (bone marrow suppression recovered to grade I).
- At least 21 days since last myelosuppressive chemotherapy (42 days if nitrosourea used).
- No use of experimental drugs or anti-cancer therapies other than chemotherapy within 28 days prior to NK cell therapy.
- At least 14 days since last long-acting hematopoietic growth factor or 3 days since short-acting growth factor.
- At least 14 days since local palliative X-ray therapy or 42 days since major bone marrow irradiation.
- At least 56 days since stem cell transplantation without whole-body irradiation, with no active graft versus host disease.
- Laboratory values within specified limits for neutrophil count, platelet count, bilirubin, creatinine, ALT/AST.
- Ability to comply with outpatient treatment, monitoring, and clinical visits.
- Parent or guardian able to consent and participant able to express consent where applicable.
You will not qualify if you...
- Symptomatic brain metastasis (stable treated brain metastasis allowed with no cerebral hemorrhage symptoms).
- History or current cardiovascular disease including significant myocardial ischemia, infarction, arrhythmia, heart failure, or low ejection fraction.
- History or current interstitial lung disease.
- Coagulation abnormalities with bleeding tendency or on anticoagulation/thrombolytic therapy.
- Venous or arterial thromboembolic events within past 12 months.
- Known bleeding or thrombotic disorders.
- Untreated long-term wounds or fractures (except tumor-related fractures).
- Major surgery, severe trauma, fracture, or ulcer within 4 weeks prior to enrollment.
- Conditions affecting oral drug absorption like swallowing difficulties or intestinal obstruction.
- History of abdominal fistula, gastrointestinal perforation, or peritonitis within past 6 months.
- Significant proteinuria in urine tests.
- Symptomatic serous cavity effusion requiring treatment.
- Active infection needing antimicrobial therapy.
- History of substance abuse or psychiatric disorders preventing quitting.
- Participation in other anti-tumor drug trials within 4 weeks.
- Recent systemic hormone or immunosuppressive treatment within 2 weeks before study drug.
- Active autoimmune disease requiring systemic treatment within past 2 years.
- Contraindications for IL-2 use.
- Active infection requiring systemic venous treatment.
- Live vaccines administered within 1 month prior to study drug (except certain influenza vaccines).
- Other untreated malignant tumors except certain superficial carcinomas.
- Conditions judged by researchers to affect study conduct or results.
- Positive viral screening for hepatitis B, hepatitis C, or HIV.
- Prior allogeneic tissue or organ transplantation.
- Poor compliance or inability to cooperate with the study.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Dongguan Taixin Hospital
Dongguan, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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