2025-524876-43-00招募中3 期
HO183 CAR T: A phase III randomized trial comparing academically produced BCMA-directed CAR T-cells (ARI0002h) with standard of care regimen in patients with relapsed/refractory multiple myeloma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
研究概览
简要总结
To compare progression free survival (PFS) of patients randomized to PoC ARI0002h CAR T-cells versus current SoC in patients previously treated with 2-4 lines of therapy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Documented historical diagnosis of Multiple Myeloma
- •Received 2 to 4 prior lines of antimyeloma therapy, including an IMiD, a PI and an anti-CD38 mAb.
- •Refractory to the last line of treatment by IMWG criteria
- •Measurable disease at screening per IMWG criteria
- •Candidates to receive at least 1 of the 5 SoC regimens (PVd, PCd, EPd, DKd or Kd)
- •Aged 18 years or older
- •Capable of giving informed consent
- •ECOG/WHO performance status of 0-2
- •Adequate hematological, renal, hepatic, pulmonary, and cardiac function
排除标准
- •Received one of the following prior therapies: BCMA-targeted therapy, T-cell engager therapy, CAR T-cell therapy, or other genetically modified T-cell therapy
- •Active or prior history of central nervous system (CNS) or meningeal involvement of MM
- •Cardiac atrial or cardiac ventricular MM involvement.
- •History of or active plasma cell leukemia, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, or amyloidosis.
- •Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- •Females who are pregnant or breastfeeding
- •Participants who are not willing to practice highly effective birth control
- •Life expectancy < 12 weeks
- •Current participation in another clinical trial
研究者
Wilfried Roeloffzen
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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