NCT06068400终止不适用
A Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Relapsed or Refractory Multiple Myeloma
Guangzhou Bio-gene Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2023年9月21日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Evaluation of Safety
研究概览
简要总结
This is a single arm, single center clinical study evaluating the safety and efficacy of CAR-T treatment for relapsed or refractory multiple myeloma.
详细描述
This study is a single arm, single center study targeting patients with relapsed or refractory multiple myeloma (r/rMM). The study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3×10^6/kg±20%~1×10^7/kg ±20% CAR positive 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients or their guardians understand and voluntarily sign an informed consent form and are expected to complete the follow-up examinations and treatments related to the study.
- •2. Aged 18-75 years, any gender.
- •3. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
- •4. Documented evidence that the patient's multiple myeloma is refractory or relapsed, defined as:
- •a) Refractory: No response to salvage therapy (no response defined as no achievement of minimal response [MR] or disease progression during treatment), or disease progression within 60 days of the last treatment, or patients who achieved MR or higher but experienced disease progression.
- •b) Relapsed: No response to any treatment, including no achievement of MR or higher in any prior treatment, but with minimal changes in M-protein without clinical progression or relapse as per the progression definition.
- •5. Measurable disease at screening based on any of the following criteria: serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or diagnosed with light-chain multiple myeloma in the absence of measurable disease in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and an abnormal κ/γ free light chain ratio, extramedullary measurable lesions, or presence of tumor cells in bone marrow biopsy.
- •6. Patients have recovered from toxicity of prior treatment, with CTCAE toxicity grade ≤2 (unless the abnormality is related to the tumor or is deemed stable by the investigator with no significant impact on safety or efficacy).
- •7. ECOG performance status score of 0-2 and an expected survival of more than 3 months.
- •8. Adequate organ function, including:
- •ALT (alanine transaminase) ≤3 times the upper limit of normal (ULN).
- •AST (aspartate transaminase) ≤3 times ULN.
- •Total bilirubin ≤1.5 times ULN.
- •Serum creatinine ≤1.5 times ULN or creatinine clearance ≥30 mL/min (calculated by Cockcroft-Gault formula).
- •Oxygen saturation ≥92%.
- •Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography with no evidence of pericardial effusion and no clinically significant electrocardiographic findings.
- •No clinically significant pleural effusion.
- •9. Establishing a required venous access for collection without any leukapheresis contraindications.
排除标准
- •1. Diagnosis or treatment of invasive malignancies other than multiple myeloma within 3 years, unless the malignancy has been curatively treated and there is no known active disease within 3 years before enrollment, or unless the patient has been fully treated for non-melanoma skin cancer with no evidence of disease.
- •2. Prior treatment with the following anti-cancer therapies (before leukapheresis for CAR-T cell production): received targeted therapy, epigenetic therapy, or investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter); received monoclonal antibody therapy within 21 days; received proteasome inhibitor therapy within 14 days; received immunomodulatory drug therapy within 7 days; received radiation therapy within 14 days (excluding bone marrow radiation ≤5% of bone marrow reserve).
- •3. Underwent hematopoietic stem cell transplantation within 2 months prior to screening.
- •4. History of central nervous system disorders.
- •5. Clinical signs of active central nervous system (CNS) involvement or manifestations of multiple myeloma meningeal involvement.
- •6. Diagnosed with Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or primary AL amyloidosis.
- •7. Positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA quantification, positive for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA, syphilis test, or Epstein-Barr virus DNA.
- •8. History of severe allergies (defined as Grade 2 or higher reactions) or known hypersensitivity to any active ingredients, excipients, mouse-derived products, or heterologous proteins included in this trial, including the conditioning regimen.
- •9. Severe cardiac diseases, including but not limited to severe arrhythmias, unstable angina, extensive myocardial infarction, New York Heart Association class III or IV heart failure, myocardial infarction within ≤6 months prior to screening, coronary artery bypass grafting (CABG) performed, except for non-vascular vagal syncope or dehydration, severe non-ischemic cardiomyopathy, and resistant hypertension.
- •10. Unstable systemic diseases, as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring drug treatment.
- •11. Had acute or chronic graft-versus-host disease (GVHD) within 6 months prior to screening or required immunosuppressive treatment for GVHD.
- •12. Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome) at screening.
- •13. Requires emergency treatment for tumor emergencies at screening (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome).
- •14. Has uncontrollable bacterial, fungal, viral, or other infections requiring antibiotic treatment.
- •15. Received blood transfusions or hematopoietic cytokine drugs affecting the patient's blood counts within 2 weeks prior to screening for planned CAR-T cell production, as determined by the investigator to affect cell preparation.
- •16. Receiving steroids or immunosuppressive drugs within 2 weeks of screening for planned CAR-T cell production:
- •a) Steroids: Received systemic corticosteroid treatment within 2 weeks of screening and judged by the investigator to require long-term systemic corticosteroid treatment (excluding inhalation or topical use); and received systemic corticosteroid treatment within 72 hours before cell infusion (excluding inhalation or topical use).
- •b) Immunosuppressive drugs: Receiving immunosuppressive drugs within 2 weeks of screening.
- •17. Underwent major surgery (excluding diagnostic surgery and biopsy) within 4 weeks prior to screening or has unhealed surgical wounds before enrollment.
- •18. Received (attenuated) live virus vaccines within 4 weeks before screening.
- •19. Has severe mental illness.
- •20. History of alcohol abuse or substance abuse.
- •21. Pregnant or lactating women and participants planning to become pregnant within 2 years after cell infusion or their partners planning to become pregnant within 2 years after cell infusion.
- •22. Patients who have contraindications to any study procedure or have other medical conditions that may place them at unacceptable risk according to the investigator 's judgment and/or clinical criteria.
研究组 & 干预措施
BCMA/GPRC5D dual CAR-T
Experimental
The study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3 × 106/kg ± 20%~1 × 107/kg ± 20% CAR positive T cells
干预措施: BCMA/GPRC5D dual CAR-T (Biological)
结局指标
主要结局
Evaluation of Safety
时间窗: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Count the Incidence of adverse events
Changes in cytokine level
时间窗: Up to 2 years after BCMA/GPRC5D dual CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after BCMA/GPRC5D dual CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ
次要结局
- Overall response(OR)(Up to 2 years after BCMA/GPRC5D dual CAR-T infusion)
- Complete response rate(CR)(Up to 2 years after BCMA/GPRC5D dual CAR-T infusion)
- Strict complete response rate(SCR)(Up to 2 years after BCMA/GPRC5D dual CAR-T infusion)
- Very good partial response rate(VGPR)(Up to 2 years after BCMA/GPRC5D dual CAR-T infusion)
- Partial response(PR)(Up to 2 years after BCMA/GPRC5D dual CAR-T infusion)
- Minimal response(MR)(Up to 2 years after BCMA/GPRC5D dual CAR-T infusion)
研究者
研究点 (1)
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