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Tests treatment safety and results for Soft Tissue Sarcoma (STS)
Official title Umbilical Cord Blood NK Cell Therapy for High-Risk Pediatric Soft Tissue Sarcoma: Efficacy and Safety Study
ClinicalTrials.gov ID: NCT06848582
What this study is testing
What is umbilical cord blood NK cells?
umbilical cord blood NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for soft tissue sarcoma (sts).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- To be eligible for the study, participants must meet all of the following criteria:
- Give informed consent and sign a written informed consent form.
- Age ≤ 18 years, no gender limitation.
- Karnofsky (≥16 years) or Lansky (\<16 years) (Appendix 2) performance status score of at least 50 (Appendix 2).
- Diagnosis of high-risk and relapsed/refractory pediatric soft tissue sarcoma, confirmed by clinical criteria, and who have undergone prior...
You likely can't join if
- Participants who meet any of the following criteria are not eligible for the study:
- Presence of symptomatic brain metastasis (patients with brain metastasis treated and symptomatically stable for at least 2 months before enrollment...
- History of or current cardiovascular disease, including ≥ II-grade myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including...
- History of or current interstitial lung disease.
- Coagulation function abnormality (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5 ULN), with bleeding tendency or receiving...
- Any venous or arterial thromboembolic event within 12 months prior to enrollment, including cerebrovascular accidents (including transient ischemic...
See the full eligibility criteria
Who can join
- To be eligible for the study, participants must meet all of the following criteria:
- Give informed consent and sign a written informed consent form.
- Age ≤ 18 years, no gender limitation.
- Karnofsky (≥16 years) or Lansky (\<16 years) (Appendix 2) performance status score of at least 50 (Appendix 2).
- Diagnosis of high-risk and relapsed/refractory pediatric soft tissue sarcoma, confirmed by clinical criteria, and who have undergone prior comprehensive treatment (surgery, chemotherapy, radiation, and/or stem cell...
- Estimated survival time of at least 12 weeks.
- Complete recovery from all acute toxicities of prior anti-cancer chemotherapy, such as bone marrow suppression with recovery to grade I.
- Myelosuppressive chemotherapy: at least 21 days after the last myelosuppressive chemotherapy (42 days if prior use of nitrosourea).
- Experimental drugs or anti-cancer therapies other than chemotherapy: not used within 28 days prior to the planned start of NK cell immunotherapy. Must be fully recovered from the clinical significant toxicity of the...
- Hematopoietic growth factors: at least 14 days after the last administration of long-acting growth factor or 3 days after the last administration of short-acting growth factor.
- X-ray therapy (XRT): at least 14 days after local palliative XRT (small field mouth) or at least 42 days after other substantive bone marrow (BM) irradiation, including prior radioactive iodine-131...
- Stem cell transplantation without whole-body irradiation (TBI): no evidence of active graft versus host disease (GvHD), and at least 56 days after transplantation or stem cell transplantation.
- Laboratory tests during the screening period must meet the following conditions: Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L (ANC ≥ 0.5 × 10\^9/L if bone marrow involvement). Platelet count (PLT) ≥ 75 × 10\^9/L (PLT...
- Ability to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during the study. For pediatric or adolescent participants, the parent/guardian must be able to understand, consent, and...
What rules you out
- Participants who meet any of the following criteria are not eligible for the study:
- Presence of symptomatic brain metastasis (patients with brain metastasis treated and symptomatically stable for at least 2 months before enrollment are eligible, but must be confirmed to have no cerebral hemorrhage...
- History of or current cardiovascular disease, including ≥ II-grade myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women), or ≥ III-IV-grade...
- History of or current interstitial lung disease.
- Coagulation function abnormality (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5 ULN), with bleeding tendency or receiving anticoagulation or thrombolytic therapy.
- Any venous or arterial thromboembolic event within 12 months prior to enrollment, including cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein...
- Known hereditary or acquired bleeding and thrombotic tendency (e.g., hemophiliacs, coagulation dysfunction, thrombocytopenia, splenomegaly).
- Long-term, untreated wounds or fractures (excluding pathologic fractures caused by tumor).
- Major surgery or severe traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment.
- Factors that significantly affect the absorption of oral drugs, such as difficulty swallowing, chronic diarrhea, and intestinal obstruction.
- History of abdominal fistula, gastrointestinal perforation, or peritonitis within the past 6 months.
- Urinary routine showing ≥ ++ proteinuria, and confirmed 24-hour urine protein ≥ 1.0 g.
- Presence of symptomatic serous cavity effusion requiring treatment (including pleural effusion, ascites, pericardial effusion); note: asymptomatic serous cavity effusion can be enrolled, symptomatic serous cavity...
- Active infection requiring anti-microbial therapy (e.g., requiring the use of antibacterial drugs, antiviral drugs, but not including chronic hepatitis B anti-hepatitis B treatment, anti-fungal drug treatment).
- History of substance abuse of psychiatric drugs and inability to quit or with psychiatric disorders.
- Participation in other anti-tumor drug clinical trials within the past 4 weeks.
- Receiving systemic hormone treatment or other forms of immunosuppressive treatment within 2 weeks prior to the first dose of the study drug.
- History of active autoimmune disease requiring systemic treatment (e.g., using disease-modifying drugs, corticosteroids, or immunosuppressive agents) within the past 2 years; note: alternative treatment (e.g., thyroid...
- Contraindications for IL-2 use.
- Active infection requiring systemic venous treatment.
- Administration of live vaccines within 1 month prior to the first use of the study drug; live vaccines against seasonal influenza, injectable inactivated virus vaccines are allowed, but nasal administration of live...
- Prior or concurrent other untreated malignant tumors, excluding cured superficial basal cell carcinoma, cervical in situ carcinoma, and superficial bladder carcinoma.
- Other conditions judged by the researcher to potentially affect the conduct of the clinical research and the determination of research results.
- Viral screening during the screening period showing any of the following: HBsAg positive and HBV DNA above the normal upper limit. Anti-HCV positive and HCV RNA positive. HIV positive.
- Prior allogeneic tissue/organe transplantation.
- Poor compliance, unable to cooperate with clinical research.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Dongguan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Dongguan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.