EUCTR2020-004768-24-FR进行中（未招募）1 期
Open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL) - BALLI-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CELLECTIS SA
- 入组人数
- 83
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
- •a.Dose Escalation phase: Patient aged =15 years and =70 years;
- •b.Dose Expansion phase: Patient aged =12 and =40 years;
- •2.Diagnosis and Prior Therapy
- •a.Dose Escalation phase: Diagnosed with R/R B-ALL; prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen. There must be no available alternative curative therapies and patients must be ineligible for allogeneic hematopoietic stem cell transplantation (HSCT), have refused HSCT, recurred after HSCT, or have active disease that prohibits HSCT at the time of enrollment.
- •b.Dose Expansion phase: Diagnosed with R/R B-ALL; prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen, and must have included a CD19 targeted treatment. There must be no available alternative curative therapies and patients must be ineligible for allogeneic hematopoietic stem cell transplantation (HSCT), have refused HSCT, recurred after HSCT, or have active disease that prohibits HSCT at the time of enrollment;
- •3.Disease burden
- •a.Dose Escalation phase: Patients must have measurable or evaluable disease in the bone marrow of at least 0.01% blasts or non-CNS extramedullary disease at the time of enrollment;
- •b.Dose Expansion phase: Patients must have measurable or evaluable disease in the bone marrow of at least 5% blasts at the time of enrollment;
- •4.CD22 Expression
- •a.Dose escalation phase: At least 70% of B-ALL blast cells expressing CD22 by flow cytometry performed as per standard practice;
- •b.Dose expansion phase: B-ALL blast cells must express CD22 by flow cytometry performed as per standard practice
- •5.Eastern Cooperative Oncology Group performance status =1; Lansky score =70 for patients =16 years
- •6.Adequate organ function, including renal and hepatic function based on the last assessment performed within the Screening Period, defined as:
- •i)Creatinine clearance =60 mL/min (assessed as glomerular filtration rate using the Cockcroft-Gault formula);
- •ii)Alanine aminotransferase and aspartate aminotransferase 3×upper limit of normal (ULN) or =5×ULN if deemed to be elevated due to leukemic involvement
- •iii)Total bilirubin 2×ULN or =3×ULN if deemed to be elevated due to leukemic involvement
- •iv)Left ventricular ejection fraction =50%
- •7. Women of childbearing potential must have a negative, highly sensitive serum pregnancy test.
- •Are the trial subjects under 18? yes
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment;
- •2. Prior CD22 directed CAR T cell therapy;
- •3. Prior monoclonal antibody therapy within 30 days prior to enrollment;
- •4. Use of other investigational products within 5 half-lives or within 14 days prior to enrollment, whichever is longer;
- •5. Use of systemic chemotherapy within 14 days prior to enrollment (except 6 weeks for nitrosoureas);
- •6. Use of rituximab, other anti-CD20 antibodies known to have the same epitope as rituximab, or anti-CD20 antibodies for which the epitope is unknown within 3 months prior to enrollment;
- •7. Planned treatment with > 20 mg of prednisone or equivalent between Days -7 and +28 of UCART22 infusion.
- •8. Burkitt cell leukemia;
- •9. More than 1 allogeneic HSCT received;
- •10. Allogeneic HSCT within 90 days prior to enrollment;
- •11. Donor lymphocyte infusion within 6 weeks prior to enrollment;
- •12. Active, acute or chronic graft-versus-host disease (GvHD). Patients should be off all immunosuppression for 6 weeks prior to enrollment;
- •13. Radioimmunotherapy or radiotherapy within 8 weeks
- •14. Hyperleukocytosis (=15,000 blasts/µL) or rapidly progressive disease.
- •15. Patients with radiologically-detected CNS leukemia or CNS-3 disease.
- •16. Presence of an active and clinically relevant CNS disorder.
- •17. Isolated extramedullary relapse (i.e., testicular, CNS);
- •18. Known infection with human immunodeficiency virus or human T-cell leukemia/lymphoma virus type 1 or active hepatitis B or active hepatitis C;
- •19. Any known uncontrolled cardiovascular disease in the previous 6 months before enrollment
- •20. History of severe recurrent viral infections or active bacterial, fungal, or viral infection not controlled by adequate treatment at enrollment;
- •21. Abnormal findings and/or clinically significant Grade =3 non hematological toxicity that might jeopardize the patient’s safety;
- •22. Evidence of another uncontrolled malignancy within 2 years prior to Screening;
- •23. Active macrophage activation syndrome (MAS);
- •24. For a patient intended to receive alemtuzumab as part of their lymphodepletion regimen (Arm FCA):
- •i)History of hypersensitivity to alemtuzumab; or
- •ii)Inability for any reason to receive appropriate anti-infective prophylaxis.
研究者
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