TCTR20210818003招募中1 期
Safety/Phase I study of PiggyBac transposon mediated Chimeric Antigen Receptor T cells targeting CD-19 in Thai patients with relapsed or refractory B-cell acute lymphoblastic leukemia and lymphoma
King Chulalongkorn Memorial Hospital, Thai Red Cross Society0 个研究点目标入组 12 人开始时间: 2021年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1.Participants must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen. Participant must have no other available treatment options for disease control.
- •1.1Participant with Philadelphia Chromosome positive ALL are eligible if the progressed, had stable disease or relapsed after two lines of therapy including tyrosine kinase inhibitors (TKIs)
- •1.2Participants with DLBCL must have progressed, has SD, or recurred after treatment regimen that include an anthracycline and an anti-CD20 monoclonal antibody
- •1.3Participant with transformed FL, MZL, or CLL/SLL must have progressed, had SD or recurred with transformed disease after initial treatment for DLBCL
- •1.4Subjects who relapse more than 12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant or have no other treatment option for disease control with in 12 months prior to enrollment
- •2.The disease must be CD19 positive either by immunohistochemistry or flow cytometry analysis on last biopsy available
- •3.Age 18-60 years
- •4.Sex: Male or female
- •5.Performance status: ECOG performance status = 0-2
- •6.Normal organ function:
- •6.1AST (SGOT) < 5 times the upper limit of normal (ULN)
- •6.2ALT (SGPT) < 5 times the upper limit of normal (ULN)
- •6.3Total bilirubin < 3 times the upper limit of normal (ULN)
- •6.4Creatinine < 5 times the upper limit of normal (ULN)
- •6.5SpO2 room air >=90%
- •7.Prior therapy wash-out
- •At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the participant is planned for leukapheresis
- •8.Participants and/or care givers must have the ability to understand and willingness to sign a written informed consent document
排除标准
- •1.Autologous transplantation within 6 weeks of planned CAR-T cell infusion.
- •2.Active GVHD that required systemic immunosuppressant with 4 weeks of enrollment
- •3.Recipient of CAR-T cell therapy outside this protocol.
- •4.Participants who have more than 20% of blast cell in the bone marrow
- •5.Active central nervous system or meningeal involvement by tumor. Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with a history of CNS or meningeal involvement must be in documented remission by CSF evaluation and contrast-enhanced MRI Imaging for at least 90 days prior to enrollment.
- •6.History of active malignancy other than non-melanoma skin cancer and carcinoma in situ (e.g. cervix, bladder, breast).
- •7.Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, Graft Versus Host Disease or psychiatric illness/social situations that would limit compliance with study requirements.
- •8.Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with potential for teratogenic or abortifacient effect. Women of child bearing potential must have negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of mother with CAR-T cells, breast feeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving CAR-T cell infusion.
- •9.Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- •10.Serologic status reflecting active HIV, hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to enrollment.
- •11.Participants who has a history of anaphylactic reaction
研究者
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