NCT03925935已完成1 期
A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
研究概览
简要总结
A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205 infusion following autologous stem cell transfusion on Day 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) who are candidates for HDT-ASCT with one of the following conditioning regimens:
- •carmustine, etoposide, cytarabine, melphalan (BEAM)
- •cyclophosphamide, carmustine, etoposide (CBV)
- •thiotepa, busulphan, cyclophosphamide (TBC)
- •additional myeloablative chemotherapy-based conditioning regimens may be permitted with the approval of the medical monitor
- •Adjunct radiation therapy to HDT will be allowed.
- •Adequate organ function is required, defined as follows:
- •Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
- •AST, ALT, and alkaline phosphatase < 3 times the upper limit of normal
- •Creatinine clearance ≥ 40 ml/min (calculated by Cockcroft Gault)
- •LVEF ≥ 45% by MUGA or resting echocardiogram
- •Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
- •Adequate performance status ECOG ≤1
- •For female subjects of childbearing potential:
- •A negative serum or urine pregnancy test at screening.
- •Subject must be willing to use a recommended method of contraception from the start of the screening period and throughout the study period.
- •For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
- •Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of conditioning therapy for at least 1 year after completion and discussion with a treating physician.
- •Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
- •Ability to provide written informed consent.
排除标准
- •History of prior ASCT.
- •Active malignancy other than the one for which the subject is undergoing HDT-ASCT. (Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible.)
- •Subjects with a serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics.
- •Active Human Immunodeficiency Virus (HIV) infection and Acquired Immunodeficiency Syndrome (AIDS).
- •Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 30 days or longer after chemotherapy treatment discontinuation if required by prescribing information for chemotherapy agents received during the study.
- •Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO.
- •Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.
研究组 & 干预措施
Experimental
Experimental
Up to 3 sequential dose escalation cohorts of AB-205
干预措施: AB-205 (Biological)
结局指标
主要结局
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
时间窗: 24 hours
次要结局
- Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5(100 days)
- Overall survival(100 and 365 days post-ASCT)
- Time to lymphoid recovery(14, 28 and 100 days post-ASCT)
- Time to platelet engraftment(First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support)
- Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea.(Day 0 to hospital discharge)
- Time to neutrophil engraftment(First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL)
- Progression-free survival(100 and 365 days post-ASCT)
- Non-relapse mortality(100 and 365 days post-ASCT)
研究者
研究点 (9)
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