A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA-25) – Substudy D - Relapsed/Refractory Hairy Cell Leukemia (HCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 18
- 主要终点
- The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy D (HCL) is ORR by central assessment defined as the proportion of subjects who achieve either complete response (CR) or partial response (PR)
研究概览
简要总结
The primary objective of ZUMA-25 is to evaluate the efficacy of brexucabtagene autoleucel in subjects with rare B-cell malignancies, by determining the Response Rates as defined within the substudies by central assessment. The primary objective of ZUMA-25 substudy D (HCL) is to evaluate the efficacy of brexucabtagene autoleucel in subjects with HCL by determining the objective response rate (ORR) by central assessment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 years of age or older at the time of signing the informed consent
- •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower
- •ECOG performance status score of 0 or
- •Adequate hematologic and end-organ function.
- •Participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
- •Individuals must have histologically confirmed hairy cell leukemia (HCL) with a need for therapy based on at least one of the following criteria: - neutrophils < 1.0 x 10^9/L - platelets < 100 x 10^9/L - hemoglobin < 11 g/dL - symptomatic splenomegaly - symptomatic lymphadenopathy
- •Individuals must have received: - At least 2 prior therapies, including at least a purine nucleoside analog (PNA) and moxetumomab pasudotox if eligible and available.
排除标准
- •Prior CAR therapy or treatment with any anti-CD19 therapy
- •HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL.
- •History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
- •History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- •Prior history of allogeneic stem cell transplant
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy D (HCL) is ORR by central assessment defined as the proportion of subjects who achieve either complete response (CR) or partial response (PR)
The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy D (HCL) is ORR by central assessment defined as the proportion of subjects who achieve either complete response (CR) or partial response (PR)
次要结局
- The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy
- • Duration of Response
- • Overall Survival
- • Progression-free survival
- • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment
- • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy
- The Substudy D (HCL) specific secondary endpoint is ORR by investigator assessment defined as the proportion of subjects who achieve either CR or PR
研究者
EU Clinical Trials Support
Scientific
Kite Pharma Inc.