NCT01685021终止2 期
A Phase IIa, Single-arm, Open-label Study of MOR00208, a Humanized Fc-Engineered Anti-CD19 Antibody, in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- MorphoSys AG
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previously treated Philadelphia-chromosome-negative B-ALL, with progression after at least one prior therapy. Patients with Philadelphia-chromosome-positive B-ALL can only be included if they are refractory or intolerant to at least one tyrosine-kinase-inhibitor.
- •Male or female patients at least 16 years of age; if the patient is less than 18 years of age, the patient must have the ability to understand and give written assent in addition to the parent's/guardian's written informed consent.
- •Patients with histologically confirmed diagnosis of B-ALL
- •Mixed phenotype acute leukemia patients who have B cell immunophenotype.
- •Patients with an Eastern Cooperative Oncology Group performance status of less than or equal to 2
- •Patients with a total bilirubin of less than or equal to 2.0 mg/dL
- •Patients with alanine aminotransferase or aspartate aminotransferase less than or equal to 2.5 times the upper limit of normal
- •Patients with a creatinine level of less than or equal to 2.0 mg/dL
- •If a female of childbearing potential, confirmation of a negative pregnancy test before enrollment and use of double-barrier contraception, confirmation of a negative pregnancy test before enrollment and use of oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy, oophorectomy, or tubal ligation
- •If a male, use of an effective barrier method of contraception during the study and for 3 months after the last dose if sexually active with a female of childbearing potential
- •Patients with the ability to understand and give written informed consent and to comply with the study protocol
排除标准
- •Patients who received previous treatment with an anti-CD19 antibody or fragments
- •Receipt of anti-CD20 therapy no greater than 4 weeks before the first study dose
- •Patients having undergone prior allogeneic stem cell transplantation within 3 months or having active graft versus host disease
- •Patients with known hypersensitivity to any excipient contained in the drug formulation
- •Patients with a New York Heart Association Class III or IV
- •History of stroke or myocardial infarction within the last 6 months
- •Patients with a history of positive human immunodeficiency virus test result (ELISA or western blot)
- •Patients with positive hepatitis serology. Hepatitis B (HBV): Patients with positive serology for hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg) or total anti-hepatitis B core antibody (anti-Hbc). Patients positive for anti- Hbc may be included if hepatitis B viral DNA is not detectable. Hepatitis C (HCV): Patients with positive hepatitis C serology (defined as positive for anti-hepatitis C virus antibody (anti-HCV) unless HCV-RNA is confirmed negative.
- •Patients with active viral, bacterial, or systemic fungal infection requiring active parenteral treatment
- •Patients who are receiving active treatment/chemotherapy for another primary malignancy or have received any treatment, including surgery, radiation, or chemotherapy, within the past 5 years (except ductal breast cancer in situ, for nonmelanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ)
- •Patients who are pregnant or breastfeeding
- •Patients with major surgery or radiation therapy within 4 weeks prior to first study dose
研究组 & 干预措施
MOR00208 (formerly Xmab5574)
Experimental
intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
干预措施: MOR00208 (formerly Xmab5574) (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Throughout during study until progression, after each treatment cycle
ORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208
次要结局
- Pharmacokinetics of MOR00208(weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start))
- Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT(Throughout during study until progression, after each treatment cycle)
- Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam(weekly, up to 7 months)
- Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity(monthly, up to 7 months)
研究者
研究点 (3)
Loading locations...
相似试验
终止
1 期
Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCLExtranodal NK/T-cell Lymphoma, Nasal TypeNCT04509466CSPC ZhongQi Pharmaceutical Technology Co., Ltd.41
Unknown
2 期
A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Gastric Cancer or Gastroesophageal Junction CancerGastroesophageal Junction CancerGastric CancerNCT05395780Maxinovel Pty., Ltd.30
进行中（未招募）
1 期
Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic SyndromesUntreated Myelodysplastic SyndromeNCT05782127Groupe Francophone des Myelodysplasies36
招募中
1 期
Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ PatientsMetastatic HER2 Positive Gastroesophageal Junction CancerNCT06650332Zhejiang Cancer Hospital90
招募中
2 期
Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell NeoplasmsB-Cell NeoplasmNCT06508931Miltenyi Biomedicine GmbH31