EUCTR2018-001018-14-GB进行中（未招募）1 期
Phase I, open label dose-escalation study to evaluate the safety, expansion, persistence and clinical activity of multiple infusions of UCART123 (allogeneic engineered T-cells expressing anti-CD123 chimeric antigen receptor) in patients with adverse genetic risk Acute Myeloid Leukaemia
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
- 18
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
入选标准
- •1.Aged between 18 and 65 years;
- •2. Weight =42 kg;
- •3. Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML), including patients with CD123 positive AML secondary to MDS, who do not achieve complete remission, and whose bone marrow blast content is < 20% after 1 or 2 courses of standard intensive induction chemotherapy. Adverse genetic risk is defined as per ELN guidelines (Döhner et al., 2017).
- •4. Patients must have received either a 3+7” regimen (consisting of 3 days of an IV anthracycline: daunorubicin at least 60 mg/m²; idarubicin 12 mg/m²; or mitoxantrone 12 mg/m², and 7 days of continuous infusion cytarabine (100-200 mg/m²)) ; or FLAG-Ida regimen (consisting of fludarabine 30 mg/m² from Day 2 to Day 6, cytarabine 1500-2000 mg/m² IV, Day 2 to Day 6; idarubicin 10 mg/m², Day 2 to Day 4);
- •5. Availability of a suitable sibling or unrelated HLA matched donor;
- •6. Adequate organ function defined as:
- •i. Creatinine clearance =60mL/minute (assessed as glomerular filtration rate using the Cockcroft & Gault formula or MDRD); and
- •ii. Alanine aminotransferase <3 × upper limit of normal (ULN) or aspartate aminotransferase <3 × upper limit of normal (ULN); and
- •iii. Bilirubin < 2 times ULN (except for patients with documented history of Gilbert’s syndrome confirmed by UGT1A1 mutation); and
- •iv. Cardiac ejection fraction >50% as assessed by echocardiography; and
- •v. Must have a minimum level of pulmonary reserve defined as Grade <2 dyspnoea and pulse oxygenation =92% on room air.
- •7. Women of childbearing potential must have a negative highly sensitive serum pregnancy test performed within 7 days prior to enrolment. Within the frame of this study, female patients of childbearing potential and male patients with partners of childbearing potential must use a highly effective method of birth control, as well as their partners, from the screening period for a duration of 12 months after UCART123 administration.
- •Nonchildbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired). Highly effective birth control methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, and sexual abstinence
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Patients with =20% blasts in bone marrow after 1 or 2 courses of standard intensive induction chemotherapy;
- •2. Patients with AML transformed from previously diagnosed myeloproliferative disorder;
- •3. Patients with APL;
- •4. Evidence of uncontrolled CNS leukaemia or evidence of CNS leukaemia on CSF examination;
- •5. AML relapsing after first complete remission;
- •6. Prior allogeneic stem cell transplant;
- •7. Therapy-related AML;
- •8. Favourable or intermediate risk AML;
- •9. Prior gene or experimental cellular therapy;
- •10. Active uncontrolled infection or organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy;
- •11. Use of other investigational products within five half-lives or within 14 days prior to start of lymphodepletion, whichever is longer; participation in non-interventional registries or epidemiological studies is allowed. In addition, treatment-related toxicities should have resolved to no more than Grade 1;
- •12. Use of rituximab and 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 or 5 half-lives prior to enrolment, whichever is longer. Any contraindication to or safety concern preventing the potential use of rituximab;
- •13. Patients may not receive = 20 mg of prednisone or equivalent between Day -7 and Day 28 of UCART123 administration. Hydrocortisone required for mineralocorticoid replacement therapy is authorized at all times as
- •needed clinically. Topical, inhaled, or nasal route of steroids are permitted;
- •14. Known infection with human immunodeficiency virus or human T-cell leukaemia/lymphoma virus type 1;
- •15. A known hypersensitivity to any of the test materials or related compounds including murine and bovine products;
- •16. Any planned medical/surgical treatment that might interfere with the ability to comply with the study requirements; or
- •17. Evidence of another uncontrolled malignancy within 2 years prior to Screening (except in situ non-melanoma skin cell cancers and in situ cervical carcinoma).
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