NL-OMON55022招募中不适用
A dose-escalation, open label phase I study to assess the safety, feasibility and preliminary efficacy of HA-1H TCR modified T cells, MDG1021, in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation with or without unmanipulated donor lymphocyte infusion. - CD-TCR-003
Miltenyi Biomedicine0 个研究点目标入组 29 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 29
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
入选标准
- •1. Relapsed or persistent disease is defined according to disease specific
- •guidelines (AML, CML, MM, ALL, MDS, MPN, MF and malignant B- or T-cell
- •lymphoma) and includes MRD positivity.
- •2. Patients positive for HLA-A*02:01 according to genotyping results
- •3. Patients positive for HA-1H
- •4. Patients who received the allo-HSCT at least 100 days preceding the
- •leukapheresis
- •5. Patients (i.e. recipient) transplanted with a sibling or unrelated HSCT
- •a. donor being HLA-A*02:01 positive and HA-1H negative, or
- •b. a donor with a single mismatch at HLA-A*02:01, being HA-1H positive or
- •Patients from whom at least 10x10^6 donor CD8+ T cells can be harvested by
- •leukapheresis
- •6. Age >= 18 years, of either sex
- •7. (Eastern Cooperative Oncology Group) ECOG performance status 0-2.
- •8. Life expectancy of at least 3 months
- •9. Patients must be able to understand and be willing to give signed informed
排除标准
- •1. Evidence of acute or chronic graft versus host disease (GVHD) >= grade II
- •2. Serologic evidence of acute or chronic hepatitis B virus infection (i.e.
- •positive for HBsAg or IgM anti-HBc). Positive HIV and HCV serology or active
- •bacterial infection
- •3. Medical or psychological conditions that would make the patient unsuitable
- •candidate for cell therapy at the discretion of the investigator. Special risks
- •to be considered:
- •a. Creatinine > 2.5 times the upper limit of normal (ULN) serum level
- •b. Total bilirubin, ALAT, ASAT > 3.0 x ULN serum level
- •c. Cardiac left ventricular ejection fraction < 35% at rest
- •d. Severe restrictive or obstructive lung disease
- •4. Clinically significant and ongoing immune suppression including, but not
- •limited to immunosuppressive agents (e.g. cyclosporine or corticosteroids (at
- •an equivalent dose of >= 10 mg prednisone per day)). Inhaled steroid and
- •physiological replacement for adrenal insufficiency is allowed
- •5. Patients with a history of primary immunodeficiency
- •6. Patients with a currently active second malignancy other than nonmelanoma
- •skin cancers or subjects with history of prior malignancy and previously
- •treated with a curative intent therapy less than 1 year ago
- •7. Patients both with urinary outflow obstructions and on dialysis or patients
- •for whom cyclophosphamide is contraindicated for other reasons
- •8. Known or suspected hypersensitivity or intolerance to IMP, cyclophosphamide,
- •fludarabine and/or tocilizumab or to any of the excipients
- •9. Participation in any clinical study < 60 days prior to first IMP
- •administration in case of antibodies and < 14 days for all other IMPs
- •10. Vulnerable patients and/or patients unwilling or unable to comply with
- •procedures required in this clinical study protocol
- •11. Pregnant or lactating women
- •12. Women of child-bearing potential not using highly effective method(s) of
- •birth control (i.e., with low failure rate < 1% per year) throughout the study
- •and/or unwilling to be tested for pregnancy. A negative serum β-hCG test is
- •required at baseline
- •13. Fertile men not agreeing to use effective contraceptive methods during the
- •clinical study
研究者
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