NCT07766317尚未招募1 期
A Phase I/II Open-Label Clinical Study of Autologous Tumor Infiltrating Lymphocyte Infusion (GT201) in the Treatment of Advanced Solid Tumors
Gritbio Medicine, Inc.0 个研究点目标入组 63 人开始时间: 2026年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 主要终点
- To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors
研究概览
简要总结
This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key eligibility criteria for inclusion in the study:
- •1 Age 18~70 years old;
- •2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;
- •3 At least one lesion that is resectable for the preparation of autologous TIL cells;
- •4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;
- •5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •6 Expected survival ≥ 12 weeks;
- •7 Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion.
排除标准
- •Subjects will be excluded from the study for one or more of the following conditions:
- •1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);
- •2 Bleeding events within 3 months prior to screening
- •3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening
- •4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;
- •5 Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association (NYHA) Class grade > grade 2;
- •6 Participants with ≥ 3 untreated central nervous system (CNS) metastases;
- •7 Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (> 10 mg/day of prednisone or equivalent);
- •8 Malignant tumors other than the target indication within 5 years;
- •9 The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use;
- •10 Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV.
- •11 Previous allogeneic bone marrow transplantation or solid organ transplantation;
研究组 & 干预措施
Participants with advanced solid tumors
Experimental
干预措施: GT201 (Biological)
Participants with advanced solid tumors
Experimental
干预措施: IL-2 and PD-1 (Biological)
结局指标
主要结局
To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors
时间窗: Upto 2 years
Incidence and severity of AEs will be graded per NCICTCAE v5.0 (Phase 1)
To assess the tolerance of GT201 and decide on the recommended Phase 2 dose.
时间窗: Upto 2 years
The safest combination will be used to determine recommended dose for Phase 2 (RP2D) (Phase 1)
To assess the Objective Response Rate (ORR) of GT201 infusion in accordance with RECIST v1.1
时间窗: Upto 2 years
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) (Phase 2)
次要结局
- To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: Objective response rate (ORR)(Upto 2 years)
- To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: duration of response (DOR)(Upto 2 years)
- To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: disease control rate (DCR)(Upto 2 years)
- To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: progression free survival (PFS)(Upto 2 years)
- To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: overall survival (OS)(Upto 2 years)
研究者
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