A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher
研究概览
简要总结
This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy.
详细描述
The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of GCC2005 in treatment of patients with relapsed or refractory NK cell and T-cell malignancies expressing CD5. Phase 1a of the study will be conducted to establish a dose range that is well tolerated by the majority of participants and to determine a safety profile of GCC2005 in participant population. Phase 1b of this study is planned to evaluate safety, PK/PD characteristics, and preliminary efficacy following single administration, reflecting the cumulative exposure level obtained with multiple administration based on the safety and tolerability assessment results confirmed in Phase 1a, and to assess dose and regimen optimization to determine the RP2D for subsequent studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
- •Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.
- •According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.
- •Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- •Participants who satisfy the criteria defined in the protocol.
- •Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Participants who comply with all procedures of this study and voluntarily give written consent
排除标准
- •Has T-ALL/T-LBL, CTCL or ALCL.
- •Participants with CNS lymphoma or any involvement of the CNS.
- •Participants who had a prior history of another malignancy over the last 3 years.
- •Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
- •Participants who have had prior CAR-T or CAR-NK therapies.
- •Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management
- •Participants with previous allogenic organ transplantation
- •Participants with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.
- •Participants with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.
- •Participants with known active Hepatitis B or C
- •Participants with presence of Grade 2 or greater toxicity from the previous treatment.
研究组 & 干预措施
Phase 1a Dose Escalation and Phase 1b Dose Expansion
Dose Confirmation of GCC2005 in Relapsed or Refractory NK and T-cell Malignancies
干预措施: GCC2005 (Drug)
Phase 1a Dose Escalation and Phase 1b Dose Expansion
Dose Confirmation of GCC2005 in Relapsed or Refractory NK and T-cell Malignancies
干预措施: Cyclophosphamide (Drug)
Phase 1a Dose Escalation and Phase 1b Dose Expansion
Dose Confirmation of GCC2005 in Relapsed or Refractory NK and T-cell Malignancies
干预措施: Fludarabine (Drug)
结局指标
主要结局
Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher
时间窗: From the time of enrollment through End of Study (up to 18 months per patient)
To evaluate the safety and tolerability of GCC2005 in patients with relapsed/refractory NK/T cell malignancies. Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
To determine MTD and RP2D: Safety(based on frequency, severity, and persistence of AEs and AEs Grade 3 or higher), efficacy (based on ORR) and pharmacokinetics
时间窗: From the time of enrollment through End of Study (up to 18 months per patient)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Frequency, severity, and persistence of AEs and AEs Grade 3 or higher using NCI CTCAE ver5.0 including CRS, and neurotoxicity based on the ASTCT criteria and acute GvHD based on the Mount Sinai Acute GvHD MAGIC guidance and chronic GvHD based on the National Institutes of Health 2014 criteria, incidence of TEAEs. Dose-limiting toxicities (DLTs)
次要结局
未报告次要终点