OncoMatch/Clinical Trials/NCT07110844
Teclistamab-Daratumumab in AL Amyloidosis
Is NCT07110844 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Teclistamab and Daratumumab and Hyaluronidase-fihj for amyloid light-chain amyloidosis.
Treatment: Teclistamab · Daratumumab and Hyaluronidase-fihj — The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: plasma cell clone-directed therapy
Exception: 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0
Patient must not have received any prior plasma cell clone-directed therapy. Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.
Lab requirements
Blood counts
ANC ≥0.75 × 10^9/L; hemoglobin ≥8.0 g/dL (RBC transfusion allowed until 7 days before C1D0); platelet count ≥50 × 10^9/L (platelet transfusions acceptable during screening)
Kidney function
eGFR ≥20 mL/min/1.73 m^2 (CKD-EPI equation)
Liver function
ALT ≤2.5x ULN; AST ≤2.5x ULN; total bilirubin ≤1.5x ULN except for Gilbert syndrome, in which case direct bilirubin ≤2x ULN
Pre-treatment clinical laboratory values meeting the following criteria during the screening phase: 1. Absolute neutrophil count ≥0.75 × 10^9/L 2. Hemoglobin level ≥8.0 g/dL; red blood cell transfusion allowed until 7 days before C1D0. 3. Platelet count ≥50 × 10^9/L; Platelet transfusions are acceptable without restriction during the Screening period 4. Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN) 5. Aspartate aminotransferase (AST) ≤2.5 times the ULN 6. Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN 7. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center · New York, New York
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