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NCT07866534

Umbilical Cord Blood Infusion to Promote Hematopoietic and Immune Reconstitution in Children With Relapsed or Refractory Malignant Solid Tumors

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

Pediatric malignant solid tumors (including neuroblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, and germ cell tumors) account for approximately 60% of childhood malignancies. Despite multimodal therapy, children with relapsed or refractory disease have poor outcomes. Repeated lines of intensive salvage chemotherapy cause cumulative damage to the hematopoietic system, resulting in profound and prolonged myelosuppression (absolute neutrophil count \<0.5×10\^9/L or platelet count \<20×10\^9/L) that often fails to recover despite standard supportive care with short-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF) and recombinant human thrombopoietin (rhTPO). This leads to chemotherapy delays that compromise treatment continuity and intensity. Umbilical cord blood (UCB) contains hematopoietic progenitor cells, NK cells, T lymphocytes, and various hematopoietic and immunomodulatory factors. UCB infusion has been shown to accelerate hematopoietic recovery after chemotherapy and may enhance anti-tumor immune function. This is a single-center, single-arm, prospective exploratory study. Approximately 10 children (aged 1-18 years) with relapsed or refractory malignant solid tumors who develop severe post-chemotherapy myelosuppression with delayed hematopoietic recovery (persistent ANC \<1.0×10\^9/L and platelets \<50×10\^9/L despite ≥7 days of rhG-CSF/rhTPO support, resulting in chemotherapy delay) will receive UCB infusion in addition to continuing background anti-tumor therapy and standardized hematopoietic supportive care. Each patient may receive up to 3 UCB infusions. The follow-up period is 12 weeks from the first infusion. The study aims to: (1) evaluate the effect of UCB infusion on promoting hematopoietic recovery and on-schedule chemotherapy completion (compared with institutional historical controls); (2) evaluate immune reconstitution after UCB infusion, including dynamics of T-lymphocyte subsets, NK cells, B cells, and serum cytokines; (3) assess the safety of UCB infusion; and (4) explore differences in hematopoietic recovery and immune reconstitution across tumor types and treatment backgrounds.

Official title: An Exploratory Study of Umbilical Cord Blood Infusion to Promote Hematopoietic and Immune System Reconstitution in Pediatric Patients With Relapsed or Refractory Malignant Solid Tumors

Key Details

Gender

All

Age Range

0 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2028-07-31

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Pediatric Cancer Solid Tumor Cancer

Interventions

OTHER

umbilical cord blood

Cryopreserved umbilical cord blood unit(s) selected by Tianjin Cord Blood Hematopoietic Stem Cell Bank (HLA-A, -B, -C, -DRB1, -DQB1 ≤5/10 match acceptable; ABO and Rh(D) compatible; TNC ≥1.5×10\^7/kg body weight). The unit is thawed in a 37-40°C water bath and infused intravenously over approximately 30 minutes with premedication (diphenhydramine and acetaminophen; dexamethasone if indicated) and continuous vital-sign monitoring. Each patient may receive up to 3 infusions, with an interval of ≥21 days between infusions.

Inclusion Criteria: 1. Age 1-18 years, any sex; 2. Histopathologically confirmed pediatric malignant solid tumor (including but not limited to neuroblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, and germ cell tumors), assessed by the investigator as high-risk, relapsed, or refractory; 3. In relapsed or refractory status requiring salvage chemotherapy; 4. Severe myelosuppression after the most recent chemotherapy cycle, meeting at least one of the following: ANC \<0.5×10\^9/L or platelet count \<20×10\^9/L; AND persistent ANC \<1.0×10\^9/L and platelets \<50×10\^9/L despite ≥7 days of standard supportive care (short-acting rhG-CSF 5 μg/kg/day and rhTPO 300 U/kg/day), resulting in a delay of ≥3 days of the next chemotherapy cycle; 5. During the chemotherapy delay period, platelet count ≥20×10\^9/L (transfusion permitted) and hemoglobin ≥60 g/L (transfusion permitted) after standard supportive care; 6. Adequate major organ function: liver function (ALT/AST ≤2.5× ULN, total bilirubin ≤1.5× ULN); renal function (creatinine clearance ≥60 mL/min/1.73 m²); cardiac function (echocardiographic shortening fraction ≥28%); 7. ECOG performance status ≤2 (or Lansky play-performance score ≥50%); 8. Expected survival ≥12 weeks; 9. The guardian fully understands the study and voluntarily signs the informed consent form, agreeing to the patient's completion of immune function monitoring (peripheral blood lymphocyte subsets, NK cells, and serum cytokines); age-appropriate assent is obtained from the child (oral assent with an illustrated assent form for ages 8-12 years; written assent with an adolescent assent form for ages 12-18 years); 10. For repeat infusions: the patient remains in relapsed/refractory status requiring continued chemotherapy and again meets the myelosuppression criterion in item 4. Exclusion Criteria: 1. Progressive disease (PD) with investigator judgment that the patient is not suitable for continued chemotherapy; 2. Concurrent second primary malignancy or prior history of other malignancies; 3. Any active autoimmune disease or history of autoimmune disease; 4. Current use of immunosuppressants, or systemic glucocorticoid therapy for immunosuppressive purposes (physiologic replacement therapy excepted), continued within 2 weeks before enrollment; 5. Known allergy to umbilical cord blood components or history of severe transfusion-related adverse reactions; 6. Active, uncontrolled infection requiring intravenous anti-infective therapy for more than 72 hours without control; 7. Known history of psychotropic drug abuse; 8. Any other condition judged by the investigator that could lead to forced early termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family/social factors affecting the safety of the participant or the integrity of study data.