NCT06614686招募中1 期
A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
研究概览
简要总结
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.
详细描述
Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have provided informed consent, understanding the study's risks and benefits, and are willing to complete the study procedures.
- •Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
- •ECOG performance status of 0-
- •Anticipated survival of at least 12 weeks.
- •Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
- •Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.
- •At least one measurable tumor lesion according to RECIST 1.
- •Suitable venous access for mononuclear cell collection.
- •Adequate major organ function.
- •Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.
排除标准
- •Inadequate washout period from prior anti-cancer treatments before leukapheresis.
- •Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
- •Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
- •Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
- •Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
- •Active infection requiring intravenous anti-infective therapy.
- •Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.
- •Primary immunodeficiency or active autoimmune disease.
- •Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.
- •Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.
- •History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
- •Allergy to protein drugs or multiple medications.
- •Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell/organ transplantation. Uncontrollable third-space fluid accumulation.
- •Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.
- •Pregnant or breastfeeding women.
- •Uncontrollable psychiatric history.
- •Other conditions deemed unsuitable for study participation by the investigator.
研究组 & 干预措施
U87 autologous CAR T-cell injection
Experimental
Two stages: dose escalation and dose expansion
干预措施: U87 autologous CAR T-cell (Drug)
结局指标
主要结局
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
时间窗: 28 days post administration of CAR-T-cells
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
次要结局
- Pharmacokinetics of U87 CAR-T cells(2 years post CAR T cell infusion)
- Pharmacodynamics of U87 CAR-T cells(2 years post CAR T cell infusion)
- Objective Response Rate (ORR), as assessed by Investigators(2 years post CAR T cell infusion)
- Duration of response (DOR), as assessed by Investigators(2 years post CAR T cell infusion)
- Overall survival (OS)(2 years post CAR T cell infusion)
- Progression-free survival (PFS), as assessed by Investigators(2 years post CAR T cell infusion)
- Disease control rate (DCR), as assessed by Investigators(2 years post CAR T cell infusion)
研究者
研究点 (1)
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