EUCTR2019-002370-31-DE进行中（未招募）1 期
Phase 1/2 study evaluating genetically modified autologous T cells expressing a T-cell receptor recognizing a cancer/germline antigen as monotherapy or in combination with nivolumab in patients with recurrent and/or refractory solid tumors (ACTengine®IMA203-101) - ACTengine® IMA203/IMA203CD8 in recurrent and/or refractory solid tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 476
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Eligibility Criteria: Initial Screening (HLA Screening, Biomarker Screening, and Leukapheresis):
- •1. Patient must have voluntarily signed a written ICF1
- •2.Patient must have pathologically confirmed advanced and/or metastatic solid tumor.
- •3.Patients = 18 years of age
- •4.ECOG PS 0 to 1
- •5.HLA phenotype: HLA-A*02:01 positive
- •6.The patient has adequate pulmonary function.
- •7.The patient has adequate organ and marrow function
- •8.Acceptable coagulation status
- •9.The patient has adequate hepatic and renal function
- •10.For leukapheresis eligibility, patient’s tumor must express IMA203/IMA203CD8-specific tumor biomarker
- •11. For HCC patients: an upper endoscopy is required
- •Eligibility Criteria: Treatment Screening (Prior to Lymphodepletion and IMA202 Infusion):
- •1.Patient must have voluntarily signed a written ICF2
- •2.Life expectancy > 3 months
- •3.ECOG PS 0 to 1
- •4.The patient has adequate hepatic function
- •5.The patient must have adequate renal function
- •6.Patients must have measurable disease according to RECIST 1.1
- •7. Confirmed and adequate production timelines and capacities
- •8.Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments.
- •9. For HCC patients only: Child Pugh score = 6
- •10.Female patients of childbearing potential must use adequate contraception
- •11.Male patients must agree to use effective contraception
- •12.The patient must have recovered from any side effects of prior therapy
- •Extension cohort B Eligibility Criteria: Nivolumab Treatment:
- •1. Patients have adequately recovered organ and marrow function
- •Note: Eligibility for combination treatment may be assessed at Day 14 or Day 21.
- •2. Patients must have recovered from infections to Grade 1 or lower
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 314
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •Eligibility Criteria: Initial Screening (HLA Screening, Biomarker Screening, and Leukapheresis):
- •1.History of other malignancies
- •2. Solid tumors indications with low target prevalence as indicated by the sponsor
- •3.The patient is pregnant or is breastfeeding
- •4.Patients with prior allogenic stem cell transplantation or solid organ transplantation
- •5.History of hypersensitivity to CY, FLU or IL-2 and Rescue medication
- •6.The patient has received systemic corticosteroids within 2 weeks prior to leukapheresis. The patient has received other anti-tumor therapies.
- •7.The patient has concurrent severe and/or uncontrolled medical disease
- •8.Any other condition that would, in the investigator’s or sponsor’s judgment, contraindicate the patient’s participation in the clinical study
- •9. Patient with any active infection (e.g., COVID-19, influenza, SARS)
- •Eligibility Criteria: Treatment Screening (Prior to Lymphodepletion and IMA203 Infusion):
- •1.Patients with active brain metastases
- •2.The patient has received any anti-tumor therapy chemotherapy, radiotherapy, or investigational therapies within 1 week prior to
- •lymphodepletion; Patients must have completed any major surgery at least 4 weeks prior to lymphodepletion
- •3.Patient, in the judgment of the investigator, is not able to tolerate lymphodepletion, low dose IL-2, and/or IMA203/IMA203CD8 treatment
- •4.The patient is pregnant or is breastfeeding
- •5.The patient has concurrent severe and/or uncontrolled medical disease
- •6.Patient with any active infection (e.g., COVID-19, influenza, SARS)
- •7.Concurrent treatment in an another clinical trial or a device study that could interfere with the IMA203/IMA203CD8 treatment after signature of ICF2.
- •8. Any condition that would, in the investigator’s or sponsor’s judgment, contraindicate the patient’s participation in the clinical study because of safety concerns or compliance with clinical study procedures
- •Extension cohort B Eligibility Criteria: Nivolumab Treatment:
- •1. Patients with a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).
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