OncoMatch/Clinical Trials/NCT05951049
A Study of AT-02 in Subjects With Systemic Amyloidosis.
Is NCT05951049 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies AT02 for amyloidosis; systemic.
Treatment: AT02 — This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02. AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: chemotherapy (melphalan, bortezomib, thalidomide, lenalidomide, cyclophosphamide) — maintenance daratumumab allowed if VGPR or CR achieved and maintained, and at least 6 months from first hematologic response
May be receiving maintenance daratumumab and must have achieved and maintained a hematologic very good partial response (VGPR) or complete response (CR), have completed chemotherapy therapy (ie, melphalan, bortezomib, thalidomide, lenalidomide, or cyclophosphamide) and be at least 6 months from first hematologic response (CR or VGPR)
Lab requirements
Kidney function
Screening eGFR ≥20 and ≤75 mL/min/1.73m2 based on CKD-EPI equation OR proteinuria not improving with UACR >700 mg/g and 24-hr urine protein >1.0gm/day
Liver function
Screening alanine transaminase (ALT) or aspartate transaminase (AST) must be ≤2.5x upper limit of normal (ULN)
Screening eGFR ≥20 and ≤75 mL/min/1.73m2 based on CKD-EPI equation, OR proteinuria that is not improving (e.g., <25% reduction in urine protein creatinine ratio (UPCR) in the last 12 months or since hematologic response, whichever is shorter) with screening urine albumin creatinine ratio (UACR) >700 mg/g based on central lab assessment of first morning void urine collected at screening and confirmed by a separate Screening 24-hr urine protein >1.0gm/day; Screening alanine transaminase (ALT) or aspartate transaminase (AST) is >2.5x upper limit of normal (ULN) [excluded]; Screening estimated creatinine clearance/eGFR using the CKD-EPI equation is <20 mL/min/1.73 m2 [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Kansas City · Kansas City, Kansas
- Cleveland Clinic · Cleveland, Ohio
- OHSU (Oregon Health & Science University) · Portland, Oregon
- Penn Presbyterian Medical Center · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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