2025-522006-21-00撤回1 期
Feasibility clinical trial of the sequential combination of AloCelyvir and activated tumor-infiltrating lymphocytes (TILs) for the treatment of children and young adults with advanced neuroblastoma
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- The primary endpoint is Dose-Limiting Toxicity (DLT) of the sequential combination of AloCelyvir plus TILs.
研究概览
简要总结
To establish the safety and tolerability of AloCelyvir in combination with TILs.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed/refractory neuroblastoma (NB) with no known curative treatment available.
- •Written informed consent (and assent, if applicable) from the patient and/or parents/legal representative for participation in the study.
- •Weight ≥ 3 kg.
- •Age between 1 month and 21 years.
- •At least one evaluable or measurable disease site by imaging according to the International Neuroblastoma Response Criteria (INRC), or measurable bone marrow disease by morphology.
- •Ability to undergo an excisional biopsy for TIL procurement. Minimum sample size: 2 × 2 cm.
- •Life expectancy > 14 weeks.
- •Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment. Sexually active females of childbearing potential must agree to use acceptable and appropriate contraceptive methods, in accordance with CTFG guidelines, during the study and for at least 12 months after lymphodepleting therapy. Sexually active male patients must agree to use condoms during the study and for at least 12 months after lymphodepletion.
- •Adequate organ function prior to initiation of therapy.
排除标准
- •Systemic anticancer therapy within 14 days prior to the first dose of AloCelyvir or 5 times its half-life, whichever is shorter.
- •Known active infection with hepatitis B or C virus, or HIV.
- •Patients with primary immunodeficiency.
- •Active autoimmune disease requiring immunosuppressive therapy.
- •Prior myeloablative therapy with autologous hematopoietic stem cell rescue within 4 weeks prior to the first dose of AloCelyvir.
- •Allogeneic stem cell transplantation within 3 months prior to the first dose of AloCelyvir.
- •Radiotherapy (non-palliative) within 14 days prior to the first dose of AloCelyvir.
- •Major surgery within the previous 14 days.
- •Presence of any ≥ Grade 3 toxicity (CTCAE) related to prior treatment.
- •Patients with symptomatic and/or untreated brain metastases. Note: patients with definitively treated brain metastases may be considered for inclusion after discussion with the sponsor.
- •History of severe immediate hypersensitivity reaction or intolerance to cyclophosphamide, fludarabine, or aldesleukin, or to any component or excipient of the manufactured TILs.
- •Known active, uncontrolled bacterial, viral, fungal, or parasitic infection.
研究组 & 干预措施
AloCelyvir
Test
干预措施: AloCelyvir (Drug)
结局指标
主要结局
The primary endpoint is Dose-Limiting Toxicity (DLT) of the sequential combination of AloCelyvir plus TILs.
The primary endpoint is Dose-Limiting Toxicity (DLT) of the sequential combination of AloCelyvir plus TILs.
次要结局
- Nature and frequency of adverse events (AEs), serious adverse events (SAEs), abnormalities in laboratory test results, vital sign measurements, and physical examination findings, graded, when applicable, according to NCI-CTCAE version 5.0.
- Response rate (complete and partial).
- Clinical benefit rate (complete response, partial response, minor response, and stable disease).
- Time from enrollment to preparation and administration of AloCelyvir.
- Time from enrollment to preparation and administration of TILs.
- Progression-free survival.
- Overall survival.
研究者
Gina Paola Mejía Abril
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
研究点 (3)
Loading locations...
相似试验
招募中
3 期
Letermovir/valganciclovir combination versus valganciclovir monotherapy for treatment of cytomegalovirus (CMV) infections in kidney transplant recipients.2023-506216-40-00Assistance Publique Hopitaux De Paris80
招募中
3 期
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen2022-500929-33-01Gilead Sciences Inc., Gilead Sciences Inc., Gilead Sciences Inc.129
招募中
3 期
A Study to Learn About a Study Medicine Called Ibuzatrelvir in People With Coronavirus Disease 2019 (COVID-19) and a Severely Compromised Immune System2024-517671-21-00Pfizer Inc.94
招募中
2 期
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 PatientsImmunodeficiencyNCT07406217Calmy Alexandra256
尚未招募
不适用
Efficacy and Safety of Oral Antiviral Therapy for Idiopathic Trigeminal NeuralgiaIdiopathic Trigeminal NeuralgiaNCT07673549Beijing Tiantan Hospital165