NCT07365059尚未招募1 期
Clinical Study on Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders
Qi deng0 个研究点目标入组 18 人开始时间: 2026年1月25日最近更新:
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
- 18
- 主要终点
- Monitor and record adverse events
研究概览
简要总结
This study is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy, evaluates the safety and efficacy of CAR-T cells, and simultaneously investigates the cellular kinetic characteristics of CAR-T cells.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria：
- •According to the World Health Organization (WHO) Classification of Haematopoietic and Lymphoid Tissue Tumours (2022), patients with relapsed/refractory plasma cell disorders that have received adequate treatment and lack effective therapeutic options, including: multiple myeloma, plasma cell leukemia, extramedullary plasmacytoma, solitary plasmacytoma, or primary amyloidosis.i) Relapsed: Disease progression occurs after one or more prior treatments, requiring salvage therapy, and does not meet the criteria for refractory disease.ii) Refractory: No response to initial treatment regimen or salvage therapy, or disease progression within 60 days after treatment. No response is defined as failure to achieve minimal response (MR) or disease progression during treatment.
- •The subject's predicted survival time is not less than three months.
- •Tumor cells confirmed to be GPRC5D positive by Flow Cytometry (FCM) or Immunohistochemistry.
- •The subject failed autologous and allogeneic hematopoietic stem cell transplantation.
- •Age 14-75 years (inclusive), both genders eligible.
- •ECOG performance status ≤
- •HGB≥70g/L(transfusion permitted).
- •The functions of vital organs need to meet the following conditions: ①Creatinine ≤ 2.5 × ULN or Cockcroft-Gault creatinine clearance > 50 ml/min (excluding decreased serum creatinine clearance due to lymphoma mass compression), Combination with hemodialysis treatment is permitted. ②LVEF≥50%,② Oxygen saturation ≥90%,③ SCr≤2.5ULN,④ALT and AST≤3ULN,TBil≤2ULN. In the investigator's judgment, if organ dysfunction is associated with the current disease, the enrollment decision will be made by the investigator.
- •Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator.
- •The subject or guardian understands and signs the Informed Consent Form (ICF).
排除标准
- •Any of the following conditions will not be eligible for enrolment:
- •Severe heart failure with left ventricular ejection fraction (LVEF) < 50%.
- •History of severe pulmonary function impairment.
- •Concurrent other progressive malignant tumors.
- •Concurrent severe infection that cannot be effectively controlled.
- •Concurrent severe autoimmune disease or congenital immunodeficiency.
- •Active hepatitis (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive with HBV DNA copy number greater than the upper limit of normal at the study center; Anti-HCV positive with HCV-RNA copy number greater than the upper limit of normal at the study center).
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
- •History of severe allergy to biological products (including antibiotics).
- •Received inactivated vaccines such as influenza vaccine, COVID-19 vaccine within 4 weeks prior to screening, or received live attenuated vaccines (such as measles, varicella vaccines) within 8 weeks.
- •Allogeneic hematopoietic stem cell transplant patients with persistent acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents.
- •Patients with other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, and patients considered unsuitable for this study by the investigator.
研究组 & 干预措施
GPRC5D CAR-T cell intravenous infusion
Experimental
干预措施: GPRC5D CAR-T cell intravenous infusion (Biological)
结局指标
主要结局
Monitor and record adverse events
时间窗: up to two years after the CAR-T cell infusion
Overall Response Rate
时间窗: up to two year after the CAR-T cell infusion
次要结局
- Cell pharmacokinetics Dynamic indicators(up to one month after the CAR-T infusion)
研究者
Qi deng
Chief Physician
Tianjin First Central Hospital
相似试验
尚未招募
1 期
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney DiseasesMembranous NephropathyNCT07389499Grit Biotechnology30
招募中
1 期
A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractory Autoimmune DiseasesNCT07333118Grit Biotechnology22
招募中
1 期
A Clinical Trial of P134 Cells in Recurrent GlioblastomaNCT07318818Tasly Pharmaceutical Group Co., Ltd26
招募中
1 期
Safety, Efficacy and Cellular Metabolic Dynamics of CT1195E in Patients With Refractory / Progressive SSCNCT07355972Union Hospital, Tongji Medical College, Huazhong University of Science and Technology12
尚未招募
1 期
A Phase I/II Study to Evaluate XNW34017 in Patients With Advanced or Metastatic Solid TumorNCT07327294Evopoint Biosciences Inc.150