NCT06144606招募中2 期
Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Relapse Free Survival (RFS)
研究概览
简要总结
This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be an adult 18 years of age or older.
- •Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia.
- •Treatment and full recovery from induction chemotherapy, with following exceptions:
- •A. Vincristine associated grade 1 peripheral neuropathy B. Steroid/asparaginase associated diabetes and/or hypertension C. Inotuzumab/chemotherapy associated cytopenias
- •Patients must be in a complete remission with Minimal Residual Disease (MRD) following an induction regimen. MRD is defined herein as a bone marrow biopsy with fewer than 5% lymphoblasts. Complete remission implies the resolution of any extramedullary and/or Central Nervous Syndrome (CNS)-2-3/parenchymal disease.
- •Be willing and able to provide written informed consent/assent for the trial.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate renal, hepatic, pulmonary, cardiac function.
- •Adequate hematopoietic reserve.
- •Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female:
- •1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
- •Subjects of both genders of child-bearing potential must be willing to practice birth control from the time of consent through 6 months after the completion of KTE-X19 infusion.
排除标准
- •Diagnosis of L3 type Burkitt's lymphoma, Mixed-Lineage Leukemia (MLL) rearranged leukemia, biphenotypic leukemia, mixed phenotype acute leukemia, blast phase of chronic myeloid leukemia, or stem-cell leukemia.
- •Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
- •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severe Congestive Heart Failure (CHF).
- •Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
- •History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.
- •History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema.
- •Active CNS/leptomeningeal leukemia.
- •Severe comorbid conditions for which life expectancy would be <6 months.
- •Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- •History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome.
- •Primary immunodeficiency or history of autoimmune disease (Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- •Corticosteroid therapy at a pharmacologic dose (> 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment.
- •Presence of any indwelling line or drain (percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
- •Live vaccine ≤ 4 weeks prior to enrollment.
- •Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
研究组 & 干预措施
Autologous CAR T-cell immunotherapy
Experimental
Tecartus will be delivered at a target dose of 1x106 cells / kg. For those >100 kg, a flat dose of 1 x108 cells will be used. Tecartus will be administered on day 0, following 1 day of rest from conditioning chemotherapy.
干预措施: Tecartus (Drug)
结局指标
主要结局
Relapse Free Survival (RFS)
时间窗: Up to 5 years
The primary endpoint is RFS, defined as the time from KTE-X19 infusion until clinical relapse or death from any cause. Patients proceeding to subsequent anti-cancer therapy, inclusive of allogeneic transplantation, without relapse will be censored in this analysis. Surviving patients not meeting criteria for relapse by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
次要结局
- Duration of Response (DOR)(Up to 5 years)
- Molecular Relapse Free Survival (MRFS)(Up to 5 years)
- Overall Survival(Up to 5 years)
- Molecular Response Rate(Up to 5 years)
- Clinical Relapse Rate(Up to 5 years)
- Rate of Cytokine Release Syndrome (CRS)(Up to 5 years)
- Rate of Immune effector cell-associated neurotoxicity syndrome (ICANS)(Up to 5 years)
- Molecular Relapse Rate(Up to 5 years)
研究者
研究点 (2)
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