EUCTR2016-004682-11-GB进行中（未招募）1 期
A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 with Anti PD-1 Antibody in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma. - ALEXANDER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 171
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, aged =18 years that provide written informed consent.
- •2. Eastern Cooperative Oncology Group performance status 0 to 1.
- •3. Histologically confirmed DLBCL and large B cell lymphoma (at last relapse) and permitted subsets.
- •4. Chemotherapy-refractory disease or Relapse after at least two lines of therapy or after ASCT.
- •5. PET-positive disease per Lugano classification.
- •6. Females of childbearing potential must have a negative serum or urine pregnancy test at screening, prior to pre-conditioning and confirmed before receiving the first dose of AUTO3.
- •7. Adequate renal, hepatic, pulmonary, and cardiac function defined as:
- •a. Creatinine clearance =40 cc/min
- •b. Serum alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) =2.5 x ULN.
- •c. Total bilirubin =1.5 x ULN.
- •d. Left Ventricular Ejection Fraction (LVEF) =50% unless the institutional lower limit of normal is lower.
- •e. Baseline oxygen saturation >92% on room air and =Grade 1 dyspnoea.
- •8. Patient has adequate bone marrow function and meets the following criteria:
- •a. Absolute neutrophil count =1.0 x 10e9/L.
- •b. Absolute lymphocyte count =0.3 x 10e9/L (at enrolment and prior to leukapheresis).
- •c. Haemoglobin =80 g/L;
- •d. Platelets =75 x 10e9/L.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 101
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Prior allogeneic haematopoietic stem cell transplantation.
- •2. Females who are pregnant or lactating.
- •3. History or presence of clinically relevant central nervous system (CNS) pathology within 3 months prior to enrolment.
- •4. Patients with active CNS involvement by malignancy.
- •5. Clinically significant, uncontrolled heart disease or a recent cardiac event.
- •6. Active bacterial, viral disease or fungal infection requiring systemic treatment.
- •7. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents in the last 2 years.
- •8. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, idiopathic pneumonitis.
- •9. Prior treatment with therapy targeting programmed cell death protein 1 (PD-1), programmed cell death ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated protein 4 (CTLA 4) or prior treatment with tumour necrosis factor receptor superfamily (TNFRSF) agonists and CD357 (glucocorticoid-induced tumour necrosis factor receptor family related protein) within 6 weeks prior to AUTO3 infusion.
- •10. Prior CD19 or CD22 targeted therapy.
- •11. The following medications are excluded:
- •a. Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to AUTO3 administration.
- •b. Immunosuppression: Immunosuppressive medication must be stopped =2 weeks prior to leukapheresis or AUTO3 infusion.
- •c. Cytotoxic chemotherapies within 2 weeks of infusion and 1 week prior to leukapheresis.
- •d. Antibody therapy use including anti-CD20 therapy within 4 weeks prior to infusion, or 5 half-lives of the respected antibody, whichever is shorter.
- •e. Granulocyte-colony stimulating factor (G-CSF) less than 10 days prior to leukapheresis.
- •f. Live vaccine =4 weeks prior to enrolment.
- •g. Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy within 2 weeks prior to starting pre-conditioning
- •chemotherapy.
- •12. Prior radiation therapy within 4 weeks or chest within 24 weeks of AUTO3 infusion .
- •13. Patients receiving any other investigational agents or concurrent biological, chemotherapy or radiation therapy.
- •14. Known allergy to albumin, dimethyl sulphoxide, cyclophosphamide or fludarabine, anti-PD-1 antibody or tocilizumab.
- •15. Contraindications to receive anti-PD1 antibody will be excluded from cohorts requiring administration this administration.
- •Phase I expansion only:
- •16. Subjects who do not have adequate caregiver support for outpatient care.
- •17. Subjects who are staying greater than 60 minutes (or whatever is permissible per institutional outpatient transplant SOP)?from the clinical trial site at the time of treatment.
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