NL-OMON53976招募中不适用
Multicenter, open-label, adaptive design phase I trial with genetically modified T-cells carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in combination with CD123 target module (TM123) for the treatment of patients with hematologic and lymphatic malignancies positive for CD123 - UC02-123-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for phase 1a dose escalation:
- •1. Male or female patients, age >= 18 years
- •2. Documented definitive diagnosis of AML or BPDCN (according to standard of
- •care testing) and CD123 positivity of >=20 % of blasts. In the case of MRD+ AML,
- •if there are insufficient blasts at screening for CD123 testing, the most
- •recent available sample with sufficient blasts should be used.
- •- Relapsed or refractory AML, defined as:
- •a. patients having received standard induction chemotherapy: either refractory
- •to standard induction treatment,
- •b. or relapse, up to 3rd relapse, including conversion to MRD positivity within
- •6 months after achieving 1st CR, or relapse (not including conversion to MRD
- •positivity only) later than 6 months after 1st CR and refractory to standard
- •salvage regimen,*
- •c. or relapse after >= 2nd CR and not eligible for curative treatment (i.e.,
- •allogeneic blood stem cell transplantation).
- •d. First relapse after allogeneic HSCT including conversion to MRD positivity;
- •subjects must be at least 2 months from HSCT at the time of screening and off
- •immunosuppressant medication for at least 1 month at the time of screening
- •(with the exception of low-dose steroids (<= 20 mg prednisone or equivalent) and
- •have no active graft versus host disease (GvHD).*
- •e. MRD positive CR measured after having received two standard induction
- •chemotherapy cycles and one line of FLT3 inhibiting compound in eligible
- •f. Patients not eligible for standard induction chemotherapy: either refractory
- •or progressive after at least 1 cycle of demethylating agents in AML patients
- •not qualifying for intensive induction chemotherapy.
- •g. Patients with rrAML having up to 30% blasts in a bone marrow
- •assessment at either screening or prescreening, or patients having between 30%
- •and 40% blasts for 2 consecutive bone marrow assessments with a minimum of 1
- •months and no more than 2 months apart and without hyperproliferative disease
- •requiring cytoreductive treatment. Exceptions to BM blast criterion are only
- •possible in minor deviations in timing and/or blast count in clinically stable
- •patients, and only with sponsor*s approval.
- •- Relapsed or Refractory BPDCN:
- •a. Patients with histological and/or cytological evidence of BPDCN in the
- •peripheral blood, bone marrow (BM), spleen, lymph nodes, skin, and/or other
- •sites that is persistent/recurrent following prior standard of care treatment
- •for BPDCN. Inclusion of BPDCN requires documented approval by the sponsor
- •before entering into (pre)screening.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Inclusion criteria for phase 1b dose expansion
- •1. Male or female patients, age >= 18 years.
- •2. Relapsed or refractory AML (according to standard of care testing), having
- •up to 30% blasts in a Bone Marrow assessment at either screening or
- •prescreening, or patients having between 30 and 40% blasts for 2 consecutive
- •bone marrow assessments with a minimum of 1 months and no more than 2 months
- •apart, and without hyperproliferative disease requiring cytoreductive
- •treatment, up to 3rd relapse, without further approved curative or
- •life-extending treatment options, and documented CD123 positivity of >= 20 % of
- •blasts. Exceptions to BM blast criterion are only possible in minor deviations
- •in timing and/o
排除标准
- •Exclusion criteria for phase 1a dose escalation:
- •1. Acute promyelocytic leukemia (t15;17)
- •2. Refractory disease under anti-leukemic treatment lasting longer than 6 months
- •3. Manifestation of AML or BPDCN in central nervous system
- •4. Bone marrow failure syndromes (e.g., Fanconi anemia, Kostman syndrome,
- •Shwachman syndrome)
- •Exclusion criteria for phase 1b dose expansion
- •1. Acute promyelocytic leukemia (t15;17)
- •2. AML with only extramedullary manifestations (e.g., chloroma, primary myeloid
- •3. Refractory disease under anti-leukemic treatment lasting longer than 6
- •4. Current manifestation of AML in central nervous system
研究者
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