2024-512978-99-00招募中2 期
AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent or Refractory Active Chronic Graft Versus Host Disease who have Received at least 2 Lines of Systemic Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 23
- 主要终点
- 1. ORR in the first 6 cycles as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in cGVHD
研究概览
简要总结
To evaluate the overall response rate (ORR) of axatilimab at 0.3 mg/kg IV Q2W, 1 mg/kg IV Q2W, and 3 mg/kg IV Q4W in patients with cGVHD after failure of least 2 prior lines of therapy.
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient must be 18 years of age or older, at the time of signing the informed consent.
- •Concomitant use of calcineurin inhibitor (CNI) or mammalian target of repamycin (mTOR) inhibitors (sirolimus or everolimus) is allowed but not required.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol. A parent/guardian should provide consent for pediatric participants unable to provide consent themselves; in addition, where applicable pediatric participants should sign their own assent form.
- •Patients who are allogeneic HSCT recipients with active cGVHD requiring systemic immune suppression. Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD
- •Patients with refractory or recurrent active cGVHD despite at least 2 lines of systemic therapy. - Refractory disease is defined as meeting any of the following criteria: -- The development of 1 or more new sites of disease while being treated for cGVHD. -- Progression of existing sites of disease despite at least 1 month of standard or investigation therapy for cGVHD. -- Patients who have not achieved a response within 3 months on their prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required. - Recurrent cGVHD is active, symptomatic disease (after an initial response to prior therapy) as defined, based on the NIH 2014 consensus criteria, by organ-specific or global assessment or for which the physician believes that a new line of systemic therapy is required.
- •Patients may have persistent, active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
- •Karnofsky Performance Scale of ≥60 (if aged 16 years or older); Lansky Performance Score of ≥60 (if aged <16 years)
- •Adequate organ and bone marrow functions evaluated during the 14 days prior to randomization.
- •Creatinine clearance (CrCl) ≥30 milliliter/minute based on the Cockcroft-Gault formula in adult patients and Schwartz formula in pediatric participants.
- •Male and/or female participants. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Concomitant use a of systemic corticosteroid is allowed but not required. Topical and inhaled corticosteroid agents are allowed. If a patient is taking corticosteroids at study randomization, they must be on a stable dose of corticosteroids for at least 2 weeks prior to Cycle 1 Day 1.
排除标准
- •Has acute GVHD without manifestations of cGVHD.
- •Female patient who is pregnant or breastfeeding.
- •Previous exposure to CSF-1R–targeted therapies.
- •Taking agents for treatment of cGVHD other than corticosteroids or either a CNI or mTOR inhibitor is prohibited.
- •For approved or commonly used agents, other than corticosteroids, CNI and mTOR inhibitor, a washout of 2 weeks or 5 half-lives, whichever is shorter, is required at study enrollment.
- •Receiving an investigational treatment within 28 days of randomization.
- •Patients should not be participating in any other interventional study.
- •Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
- •History of acute or chronic pancreatitis.
- •History of myositis.
- •History or other evidence of severe illness, uncontrolled infection or any other conditions that would make the patient, in the opinion of the Investigator, unsuitable for the study.
- •Participants with acquired immune deficiency syndrome (AIDS).
- •Patients with a of history of latent or active tuberculosis (TB) before screening; signs or symptoms suggestive of active TB upon medical history and/or physical examination; recent close contact with a person with active TB; positive QuantiFeron TB test at screening.
- •Hepatitis B (defined as hepatitis B virus [HBV] surface antigen positive and HBV core antibody positive, with positive HBV deoxyribonucleic acid [DNA], or HBV positive core antibody alone with positive HBV DNA. Hepatitis C (defined as positive hepatitis C [HCV] antibody with positive HCV ribonucleic acid [RNA]).
- •Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of randomization, unless previously treated with curative intent and approved by Sponsor's Medical Monitor (for example, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).
结局指标
主要结局
1. ORR in the first 6 cycles as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in cGVHD
1. ORR in the first 6 cycles as defined by the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in cGVHD
次要结局
- 1. mLSS
- 2. - ORR, - DOR, - SRR, - Organ-specific and joints and fascia response rate, - Average daily corticosteroid dose, - Discontinue corticosteroid, - Average daily CNI dose, - Discontinue CNI.
- 3. - AEs and SAEs, - Vital signs, safety laboratory parameters, physical/neurological examination, ECG, and Karnofsky/Lansky performance scale.
- 4. PK parameters and patient factors.
- 5. CSF-1, IL-34 levels.
- 6. Circulating monocyte number and phenotype.
- 7. Baseline circulating monocyte number and phenotype.
研究者
Patrick Hardesty, PharmD, MS
Scientific
Syndax Pharmaceuticals Inc.
研究点 (23)
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