NCT07371403招募中不适用
MB-CART19.1 in Patients With Relapsed/Refractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.
研究概览
简要总结
Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 1 year as long as if deemed fit by treating investigator
- •CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.
- •Patients with relapsed or refractory disease with 0.01% or higher blasts in the bone marrow, or patients with confirmed disease progression as demonstrated by FDG PET-CT or CT/MRI of the affected lymph node or spleen after at least 2 cycles/lines of chemotherapy are eligible for enrollment. For patients with Philadelphia-positive disease, a second-generation or higher TKI must have been utilized in one of the treatment lines.
- •Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- •Estimated life expectancy > 12 weeks
- •Karnofsky or Lansky (age dependent) performance score ≥ 60
- •Patients and/or parents must give their written informed consent/assent.
- •CNS and/or testicular involvement are allowed, only if cleared and in the presence of systemic involvement.
排除标准
- •Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator.
- •Persistent extramedullary disease.
- •Isolated CNS and/or testicular disease.
- •Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
- •Active hepatitis B, C or HIV
- •Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
- •History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.
- •Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC < 65%) or an oxygen requirement of >28% O2 FiO2 or active pulmonary infection.
- •Cardiac function: Left ventricular ejection fraction <50% by echocardiography
- •Renal function: Creatinine clearance <50 mL/min/1.73 m2
- •Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT > 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.
- •Pregnant or breast-feeding females
- •Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (<0.5 mg/kg/day of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte
研究组 & 干预措施
MB-CART19.1
Experimental
干预措施: MB-CART19.1 (Genetic)
结局指标
主要结局
Proportion of enrolled patients for whom MB-CART19.1 product is successfully manufactured on-site and meets release criteria.
时间窗: From patient enrollment through completion of manufacturing and release testing; estimated 2-4 weeks per patient and up to 12 months for the full cohort.
Assessment of the feasibility and success rate of on-site manufacturing of MB-CART19.1, defined as the proportion of enrolled patients whose cell product is produced and meets established release specifications.
次要结局
- Overall response rate (ORR) (CR, CR with incomplete hematologic recovery (CRh)) on day 28.(Up to approximately 28 days after the last patient infusion.)
- Duration of response time from first documented response to progression or death up to 12 months post-infusion(Up to 12 months post-infusion)
- Rate of measurable residual disease (MRD) negativity at 1-, 3-, 6- and 12-month intervals(at 1-, 3-, 6- and 12-month intervals)
- MB-CART19.1 manufacturing turnaround time(From leukapheresis to product release (estimated 2 weeks per patient).)
- Overall incidence and severity of adverse events(From infusion through 12 months post-infusion per patient.)
- Overall incidence and severity of MB-CART19.1- specific adverse events (cytokine release syndrome (CRS))(From infusion through 12 months post-infusion per patient.)
- Overall incidence and severity MB-CART19.1-specific adverse events (Immune effector cell associated neurotoxicity syndrome (ICANS))(From infusion through 12 months post-infusion per patient.)
研究者
Zaid Abdel Rahman, MD
Consultant Hematology, Stem Cell Transplantation and Cellular Therapies
King Hussein Cancer Center
研究点 (1)
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