Allogeneic Stem Cell Transplantation Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory Solid Tumors

University of Florida2 个研究点分布在 1 个国家目标入组 27 人2026年2月11日

适应症Neuroblastoma Rhabdomyosarcoma Synovial Sarcoma Peripheral Nerve Sheath Tumors Clear Cell Sarcoma Alveolar Soft Part Sarcoma Desmoplastic Small Round Cell Tumor Chordoma Rhabdoid Tumor Epithelioid Sarcoma Myoepithelial Tumor Osteosarcoma Ewing Sarcoma

干预措施Miltenyi CliniMACS Prodigy ® system Zoledronic acid

概览

阶段: 1 期
干预措施: Miltenyi CliniMACS Prodigy ® system
疾病 / 适应症: Neuroblastoma
发起方: University of Florida
入组人数: 27
试验地点: 2
主要终点: Disease-free survival rate
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.

While solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.

By utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed/refractory solid tumors and promote an improved event-free survival and overall survival.

This study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.

注册库

clinicaltrials.gov

开始日期

2026年2月11日

结束日期

2030年2月1日

最后更新

上个月

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

University of Florida

责任方

Sponsor

入排标准

入选标准

•Patients 6 months to ≤ 25 years old
•Relapsed/Refractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \>20% chance of cure with the following diseases:
•neuroblastoma (high risk with relapsed or refractory disease),
•relapsed/refractory rhabdomyosarcoma,
•relapsed/refractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),
•High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,
•Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor
•relapsed/refractory bone tumors: osteosarcoma and Ewing sarcoma/PNET, or
•other high-risk solid tumors with \<10% expected survival with conventional treatment.
•Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included.)

排除标准

•Patients with documented uncontrolled infection at the time of study entry are not eligible.
•a. Uncontrolled infection is patient without treatment antimicrobials and/or demonstrating progression despite antimicrobials
•Demonstrated lack of compliance with medical care, as determined by the treating physician.
•Patients who have received an allogeneic HSCT within 6 months.
•Patients who do not have an eligible allogeneic donor available.
•Patients with a life expectancy \<3 months
•Patients not meeting inclusion criteria for organ function.
•Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.
•Females who are known to be pregnant or breastfeeding.
•History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.