OncoMatch/Clinical Trials/NCT07110844
Teclistamab-Daratumumab in AL Amyloidosis
Is NCT07110844 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07110844 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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