NCT07638982尚未招募1 期
An Open-label, Phase I Trial, With an Expansion Cohort: Macrophage Conditioning to Synergize With CAR-T in High-risk Lymphoma (MAC-SHIFT)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 29
- 试验地点
- 1
研究概览
简要总结
Axatilimab + CAR-T in High-Risk Lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically confirmed large B-cell lymphoma
- •Presence of one or more high-risk features
- •Eligible to receive CAR-T according to the FDA label
- •Measurable disease by CT or PET
- •Adequate organ function unless related to lymphoma involvement:
- •Pulse oximetry ≥ 92% on room air
- •Ejection Fraction ≥ 40%
- •ALT/AST < 5x ULN
- •Bilirubin < 3 x ULN
- •Calculated or measured creatinine Clearance ≥ 30 mL/min
排除标准
- •Second malignancy with a high metastatic potential within 3 years
- •Active CNS involvement. Treated CNS disease is allowed
- •Active HBV or HCV infection.
- •Active uncontrolled infections
- •Known HIV positive status
- •Allogeneic transplant within 100 days of enrollment
- •Active acute or chronic graft versus host disease
- •History of acute or chronic pancreatitis
- •History of myositis
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Phase 2 Study of Axatilimab at 3 Different Doses in Patients with Chronic Graft Versus Host Disease.2024-512978-99-00Syndax Pharmaceuticals Inc.67
撤回
2 期
Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS TrialHematopoietic and Lymphatic System NeoplasmNCT07349771Mayo Clinic72
招募中
2 期
Study to treat adult patients with Very High-Risk T-cell Acute Lymphoblastic Leukemia (ALL) with Daratumumab in addition to the National ALL treatment program2024-511627-34-00Fondazione Gimema Franco Mandelli Onlus31
招募中
1 期
OH2 Injection in Combination With BS006 Injection for Advanced Solid TumorsNCT07382531Binhui Biopharmaceutical Co., Ltd.30
招募中
1 期
Neoadjuvant Chemotherapy, Anti-PD-1 Antibody and Sitagliptin for Locally Advanced pMMR CRCColorectal CancerNCT07365592Second Affiliated Hospital, School of Medicine, Zhejiang University138