EUCTR2019-004323-20-NL进行中（未招募）1 期
Phase 1/2a, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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
- •Must have a CLDN6-positive tumor regardless of tumor histology
- •defined as = 50% of tumor cells expressing = 2+ CLDN6 protein using a
- •semi-quantitative immunohistochemistry (IHC) assay for specific
- •detection of CLDN6 protein expression in formalin-fixed, paraffinembedded neoplastic tissues.
- •-Must have measurable disease per RECIST 1.1 (except for germ cell
- •tumor or ovarian cancer patients).
- •-Germ cell cancer patients without initial measurable disease per RECIST
- •1.1 and evaluable by cancer antigen (CA)-125, alphafetoprotein (AFP) or
- •human chorionic gonadotropin (hCG; as applicable) are eligible for the
- •-Ovarian cancer patients without initial measurable disease per RECIST
- •1.1. and evaluable by CA-125 are eligible for the trial.
- •-Must have a histologically confirmed solid tumor that is metastatic or
- •unresectable and for which there is no available standard therapy likely
- •to confer clinical benefit, or patient who is not a candidate for such
- •available therapy.
- •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 148
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •-Have received prior CAR-T therapy, except CLDN6 CAR-T/CLDN6 CART(A) therapy.
- •-Have received vaccination with live virus vaccines within 6 weeks prior to the start of LD.
- •-Receives concurrent systemic (oral or intravenous [i.v.]) steroid therapy > 10 mg prednisolone daily, or its equivalent, for an underlying condition.
- •-Current evidence of new or growing brain or spinal metastases during screening. Patients with known brain or spinal metastases may be eligible if they:
- •-Had radiotherapy or another appropriate therapy for the brain or spinal metastases,
- •-Have no neurological symptoms,
- •-Have stable brain or spinal disease on the computer tomography or magnetic resonance imaging scan within 4 weeks before signing of the informed consent,
- •-Must not be undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for the last 14 d prior to screening (= 10 mg prednisolone daily or equivalent),
- •-Do not require steroid therapy within 7 d before the first dose of CLDN6 CAR-T/CLDN6 CAR-T(A),
- •-Do not have anticipated imminent fracture or cord compression due to spinal bone metastases.
- •-Has a history of another primary cancer within the 2 years prior to enrollment except for the following: non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, prostate cancer with currently undetectable prostate specific antigen, or other non-metastatic carcinoma that has been in complete remission without treatment for more than 2 years.
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