This retrospective multicenter study across 11 German centers evaluated the efficacy and safety of teclistamab (a BCMA×CD3 bispecific antibody) in 52 heavily pretreated adults with relapsed/refractory AL amyloidosis, with a median follow-up of 8.8 months (data cut-off September 30, 2025). All patients had prior daratumumab exposure; median prior lines were 2 (range 1–8).
Hematologic response (≥VGPR) was achieved in 81% by Day 15 and 95% by 3 months; flow-MRD negativity in 96% (23/24) tested. Cardiac response (≥PR) at 6 months: 65%; renal response (≥PR) at 6 months: 78%. One-year OS was 83%; median OS not reached. Six of 9 deaths were due to bacterial infections. Immunoglobulin replacement therapy (IRT) reduced Grade 3/4 infection risk 2.01-fold and fatal infection risk 6.14-fold.
- Retrospective design with missing data for some patients and no standardized treatment protocol (dose/frequency at physician discretion). - Relatively short median follow-up of 8.8 months limits long-term survival and durability conclusions. - IRT comparison is observational and non-randomized, introducing confounding.
Teclistamab produces rapid, deep hematologic and organ responses in relapsed/refractory AL amyloidosis, even in patients with advanced cardiac or renal disease. **IRT should be started early** in all patients receiving teclistamab, as it reduced fatal infection risk more than 6-fold in this cohort.
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