NL-OMON53869已完成不适用
A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T cells (WU-CART-007) in Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) - WU-CART-007
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Wugen, Inc.
- 入组人数
- 4
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
- 12 至 99（—）
入选标准
- •Evidence of relapsed or refractory T-ALL or T-LBL, as defined by World Health
- •Organization (WHO) classification with bone marrow with >= 5% lymphoblasts by
- •morphologic assessment or evidence of extramedullary disease at screening.
- •Relapsed or refractory disease defined as at least one of the following
- •a. Primary refractory: failure to achieve CR after induction chemotherapy, per
- •investigator.
- •b. Early Relapse: relapsed disease within 12 months of initial diagnosis.
- •c. Late Relapse (relapsed refractory disease): relapsed disease after 12 months
- •of initial diagnosis AND failure of re-induction therapy after disease
- •recurrence.
- •d. Relapsed or refractory disease after allogeneic transplant, and meet the
- •following criteria:
- •i. There must be histological confirmation of relapse after HSCT of T-ALL or
- •ii. Undergone allogeneic HSCT >90 days prior to enrollment from a match related
- •or unrelated donor, cord blood donor, haplo-identical, or autologous stem cells.
- •iii. Off all immunosuppressive medications for a minimum of 2 weeks with the
- •exception of physiologic doses of corticosteroids,
- •iv. No prior history of Grade 2 or greater (per Cairo-Bishop) veno-occlusive
- •disease (VOD), or active graft versus host disease (GvHD) (see exclusion
- •criteria below for exceptions).
- •Adequate renal, hepatic, respiratory, and cardiovascular function, as defined
- •in the body of the protocol.
- •Life expectancy >12 weeks
- •Age: Lower age limit of 12 years. Adolescents ages 12-17 will be eligible for
- •enrollment based on:
- •o The recommendation and approval of the DSC following review of safety
- •data and clinical benefit from prior and current dose levels.
- •o Consultation with the appropriate regulatory agencies after submission
- •of the aforementioned data.
- •ECOG/Karnofsky performance status 0 or 1 at screening (Adults age >16) or
- •Lansky Performance Status 60 and above (adolescents <= 16),
- •Ability to understand the nature of this study, comply with protocol
- •requirements, and give written informed consent. For minors, legal guardian
- •willingness to give written informed consent with patient assent, where
- •appropriate.
- •Willing to participate in WUC-007-02 for long-term follow up.
排除标准
- •Patients will be excluded from study entry if:
- •They have received previous treatment with any prior anti-CD7
- •Have not recovered from the effects of previous therapy.
- •Wash-out period of at least 5 half-lives from the last dose of any
- •investigational therapy prior to screening period.
- •Have active or latent hepatitis B or active hepatitis C, any uncontrolled
- •infection, or untreated HIV positive.
- •Have any serious active infection at the time of treatment, or another
- •serious underlying medical condition that would impair the ability of the
- •patient to receive protocol treatment.
- •Have Grade 2 to 4 acute or extensive chronic GvHD requiring systemic
- •immunosuppression (steroids). Grade 1 GvHD not requiring
- •immunosuppression is acceptable and grade 2 skin GvHD if treated with
- •topical therapy only is acceptable.
- •Have psychological, familial, sociological, or geographical conditions
- •that do not permit compliance with the protocol.
- •Pregnant or nursing (lactating) women
- •Require prohibited medications or treatments, eg, steroids, or antineoplastic
- •agents (fully defined in Section 6.2 criterion # 13.
- •Treated with anti-T cell monoclonal antibodies
研究者
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