ISRCTN83349329进行中（未招募）1 期
A phase I study of VAC85135, a neoantigen vaccine regimen, concurrently administered with ipilimumab for the treatment of myeloproliferative neoplasms
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 16/02/2024:
- •1. Be positive for a CALR (calreticulin) mutation: Type 1 or Type 2; Type 1-like, or Type 2-like may be considered with Sponsor approval; or positive for the JAK2V617F (Janus kinase 2 with valine 617 to phenylalanine mutation) mutation with HLA-A02:01 (human leukocyte antigens) per medical history or local testing.
- •2. Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 or 2
- •3. Have the following hematologic laboratory values: Leukocytes greater than or equal to (>=) 1.5*10^9 per liter, Neutrophils >=1.0*10^9 per liter, Platelets >=20*10^9 per liter, Hemoglobin greater than (>) 7 gram per deciliter (g/dL)
- •4. Have the following chemistry laboratory values: Alanine aminotransferase (ALT): less than or equal to (<=) 3*upper limit of normal (ULN), aspartate aminotransferase (AST): <=3*ULN, total bilirubin: <=1.5*ULN, and glomerular filtration rate >=40 milliliter per minute (mL/min)
- •5. A female participant of childbearing potential must agree to all the following during the study and for 6 months after the last dose of study treatment: use a barrier method of contraception, use a highly effective preferably user-independent method of contraception, not donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction, not plan to become pregnant, not to breast-feed
- •6. A male participant must agree to all the following during the study and for 90 days after the last dose of study treatment: wear a condom when engaging in any activity that allows for the passage of ejaculate to another person, not to father a child, not to donate sperm or freeze for future use for the purpose of reproduction
- •Previous inclusion criteria:
- •1. Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 or 2
- •2. Have the following hematologic laboratory values: Leukocytes greater than or equal to (>=) 1.5*10^9 per liter, Neutrophils >=1.0*10^9 per liter, Platelets >=20*10^9 per liter, Hemoglobin greater than (>) 7 gram per deciliter (g/dL)
- •3. Have the following chemistry laboratory values: Alanine aminotransferase (ALT): less than or equal to (<=) 3*upper limit of normal (ULN), aspartate aminotransferase (AST): <=3*ULN, total bilirubin: <=1.5*ULN, and glomerular filtration rate >=40 milliliter per minute (mL/min)
- •4. A female participant of childbearing potential must agree to all the following during the study and for 6 months after the last dose of study treatment: use a barrier method of contraception, use a highly effective preferably user-independent method of contraception, not donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction, not plan to become pregnant, not to breast-feed
- •5. A male participant must agree to all the following during the study and for 90 days after the last dose of study treatment: wear a condom when engaging in any activity that allows for the passage of ejaculate to another person, not to father a child, not to donate sperm or freeze for future use for the purpose of reproduction
排除标准
- •Current exclusion criteria as of 16/02/2024:
- •1. History of any significant medical condition per investigators judgment (example: severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heart condition, insulin-dependent diabetes mellitus)
- •2. Serious known clinically relevant allergies or earlier anaphylactic reactions
- •3. Currently pregnant or breastfeeding
- •4. Prior treatment with any Janus kinase 1/2 (JAK 1/2) inhibitor
- •5. Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information
- •Previous exclusion criteria:
- •1. History of any significant medical condition per investigators judgment (example: severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heart condition, insulin-dependent diabetes mellitus)
- •2. Serious known clinically relevant allergies or earlier anaphylactic reactions
- •3. Currently pregnant or breastfeeding
- •4. Prior treatment with any Janus kinase 2 (JAK2) inhibitor
- •5. Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information
研究者
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