ISRCTN11885863进行中（未招募）1 期
A single-arm, open-label, single-center study of GC197 injection in relapse and refractory B cell malignancies
Gracell Biotechnologies Co., Ltd0 个研究点目标入组 15 人开始时间: 2020年1月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- 性别
- All
入选标准
- •1. 2 to 70 years
- •2. Diagnosed with relapsed and refractory CD19+ B cell malignancies
- •3. Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- •4. Life expectancy =12 weeks
- •5. Adequate organ function defined as:
- •a. Serum ALT/AST =2.5 ULN
- •b. Creatinine clearance (as estimated by Cockcroft Gault) =60 mL/min
- •c. PT and APTT =1.5 ULN
- •d. Total bilirubin =1.5 ULN
- •e. Cardiac ejection fraction =45%
- •f. No clinically significant ECG findings
- •g. Baseline oxygen saturation >90% on room air
- •6. Agreement to the use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy
- •7. Quantifiable tumor burden
- •8. Informed consent given
排除标准
- •1. Have other tumors (except non-melanoma and cervical carcinoma in situ, bladder cancer, breast cancer that have a disease-free survival of more than 5 years)
- •2. Severe mental disorders
- •3. History of hereditary diseases including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome
- •4. Grade 2-4 acute graft-versus-host disease (GVHD( (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria)
- •5. Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically prominent heart diseases within one year before enrollment;
- •6. History or presence of CNS disorder including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
- •7. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA;
- •8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled;
- •9. Severe allergies
- •10. History of autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression/systemic disease-modifying agents within the last 2 years
- •11. History of pulmonary fibrosis
- •12. Involvement in other clinical trials = 4 weeks prior to enrollment
- •13. Presence of concomitant disease that requires systemic steroids or other immune suppressive therapy during the study period in the researcher's judgment
- •14. Patients who are contraindicated to cyclophosphamide, fludarabine, or melphalan
- •15. Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) =6 weeks prior to enrollment
- •16. Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan
- •17. Pregnant and lactating women
- •18. Any other conditions that the researcher thinks it is inappropriate for the subject to anticipate the trial
研究者
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