NCT04754100已完成1 期
A Phase 1, Open-Label Study of the Safety, Tolerability, and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) in Subjects With Relapsed/Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Number Of Participants With Treatment-related Adverse Events
研究概览
简要总结
This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed or refractory multiple myeloma, as well as to define the recommended Phase 2 dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Relapsed/Refractory Multiple Myeloma
- •Confirmed diagnosis and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group criteria and following prior therapy for multiple myeloma (MM)
- •Relapsed or refractory MM requiring current treatment
- •Previously failed ≥ 3 prior regimens (after at least 2 cycles of medication per regimen) and included at least 1 immunomodulatory drug, 1 proteasome inhibitor, and an anti-CD38 antibody agent
- •Participants must have measurable disease as defined by at least 1 of the following:
- •Serum M-protein ≥ 0.5 grams/deciliter (dL) by serum protein electrophoresis or for immunoglobulin A (IgA) myeloma, by quantitative IgA; or
- •Urinary M-protein excretion at least 200 milligrams (mg)/24 hours; or
- •Serum free light chain whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio
- •Estimated life expectancy ≥ 3 months
- •No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the principal investigator
排除标准
- •Concurrent invasive malignancy
- •Participants who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose within 4 weeks before agenT-797
- •Prior radiotherapy within 2 weeks of start of study treatment
- •Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug
研究组 & 干预措施
Allogeneic iNKT Cells
Experimental
3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days [2 weeks]).
干预措施: agenT-797 (Drug)
结局指标
主要结局
Number Of Participants With Treatment-related Adverse Events
时间窗: Baseline through Day 28 post cell infusion
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Number Of Dose-limiting Toxicities
时间窗: Baseline through Day 14 post cell infusion
次要结局
- Persistence Of agenT-797 In Peripheral Blood(Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0,5, 1, 2, and 4 hours post cell infusion), Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12)
- Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II(Baseline/Day 1 (pre-infusion), Day 22, Week 6, and end of study visit (up to 12 months))
- Overall Response Rate (ORR)(End of study visit (up to 12 months))
- Duration Of Response (DOR)(End of study visit (up to 12 months))
- Duration Of Clinical Benefit(End of study visit (up to 12 months))
- Time To Response (TTR)(End of study visit (up to 12 months))
研究者
研究点 (3)
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