NCT06589089招募中2 期
Prospective Study of Autologous Hematopoietic Stem Cell Boost to Improve Myelosuppression in B-NHL Patients with High-risk Immunologic Hematologic Toxic After Chimeric Antigen Receptor T-Cell Immunotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 1-year overall survival
研究概览
简要总结
This is a prospective, single-arm, open study to observe the efficacy and safety of the CART-SCB regimen (Clinical Regimen for the Prospective Study of Autologous Hematopoietic Stem Cell Boost for the Improvement of Bone Marrow Suppression in Patients with High-Risk Immunohematologic Toxicity Lymphoma After Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy Therapy) . After the patient has completed CAR-T therapy, if the patient has unrelieved hematologic toxicity, consider infusing a reserve of stem cells; if myelosuppression has not been significantly relieved, stem cell infusion can be performed again.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older and gender-neutral;
- •Diagnosis of B-cell non-Hodgkin lymphoma confirmed histologically or cytologically according to World Health Organization 2016 criteria;
- •Prior CAR-T cell immunotherapy;
- •Patients who are at high risk according to the CAR-HEMATOTOX score prior to leukapheresis; or patients who are clinically considered potentially at high risk for hematologic toxicity following immunotherapy (including age ≥60 years; or Eastern Cooperative Oncology Group (ECOG) Performance Status≥ 2 points; or number of prior lines of therapy ≥ 2, etc.);
- •Myelosuppression as determined by the investigator has occurred after CAR-T therapy;
- •Have a storage of stem cell;
- •Stable lymphoma disease status (final investigator-assessed efficacy CR/PR);
- •Bone marrow biopsy to rule out hemophilia/infection/bone marrow infiltration;
- •Adequate organ function;
- •Able to provide written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule;
- •Patients of childbearing potential must be willing to use highly effective contraception for the duration of the study, and for 120 days after the last dose of treatment.
排除标准
- •History of allogeneic hematopoietic stem cell transplantation;
- •History of epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
- •Presence of or current concurrent other malignancies within the past 2 years, with the exception of cured carcinoma in situ of the uterine cervix, non-melanoma skin cancers, and superficial bladder tumors (Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane));
- •Suffering from severe cardiovascular disease: grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, or cardiac ultrasound suggestive of a left ventricular ejection fraction (LVEF) <50%;
- •Allergy to any investigational drug or excipient;
- •Presence of any active autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allograft transplantation, or patients with prolonged and heavy use of hormones or use of other immune-modulating agents or other patients who, as assessed by the Investigator Patients who are considered to have an impact on study treatment;
- •Have an active infection;
- •History of uncontrolled systemic disease, including diabetes mellitus, hypertension, and acute pulmonary disease;
- •Known human immunodeficiency virus (HIV) infection;
- •Presence of an underlying medical condition or alcohol/substance abuse or dependence that is not conducive to the administration of study medication, or that may interfere with the interpretation of results, or that puts the patient at high risk for developing treatment complications;
- •End-organ damage due to autoimmune disease (e.g., Crohns disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years, or the need for systemic immunosuppression or other systemic disease-control medications.
研究组 & 干预措施
Patients treated with stem cell boost
Experimental
If the patient continues to have unrelieved hematologic toxicity after CAR-T cell therapy, consider infusing a reserve of stem cells; If there is no significant recovery from myelosuppression, another stem cell infusion can be performed.
干预措施: autologous hematopoietic stem cell (Drug)
结局指标
主要结局
1-year overall survival
时间窗: 1 year after CAR-T cell infusion
Overall survival was defined as the time from the date of leukapheresis to the date of death from any cause.
次要结局
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0(End of treatment visit (1 years after stem cell infusion))
- Best objective response rate(End of treatment visit (1 years after stem cell infusion))
- Best complete response rate(End of treatment visit (1 years after stem cell infusion))
- Time to reponse(End of treatment visit (1 years after stem cell infusion))
- Duration of response(End of treatment visit (1 years after stem cell infusion))
- Progression-free survival(End of treatment visit (1 years after stem cell infusion))
- Overall survival(End of treatment visit (1 years after stem cell infusion))
- Overall days of hospitalization(End of treatment visit (1 years after stem cell infusion))
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)Multiple MyelomaNCT05632380Institute of Hematology & Blood Diseases Hospital, China20
招募中
3 期
The pilot study of autologous hematopoeitic stem cell transplantation in neuromyelitis optica patients at Siriraj HospitalEffectiveness of autologous hematopoietic stem cell transplantation in aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder patientsneuromyelitis optica spectrum disorderaquaporin-4 antibodyautologous hematopoiectic stem cell transplatationTCTR20210716002Faculty of Medicine Siriraj Hospital, Mahidol University10
已完成
2 期
Autologous Hematopoietic Stem Cell Transplantation for Allogeneic Organ Transplant ToleranceComplication of Transplanted Organ, NosNCT02549586Gary A Levy, O. Ont. MD. FRCP AGAF5
招募中
2 期
Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia ALLNCT06608342Institute of Hematology & Blood Diseases Hospital, China20
招募中
1 期
An Open-label Study of a Gene Therapy Product (Vebeglogene Autotemcel) in Transfusion Dependent Beta-ThalassemiaBeta-ThalassemiaNCT06308159Lantu Biopharma6