The Amyloidosis Research Consortium’s Executive Director of Research, Kristen Hsu, discussed the current clinical trial landscape in AL amyloidosis. She reviewed trials currently recruiting patients, trials expecting to share results this year, and trials that are planned to open in the future.
Original Presentation Date:
November 5, 2025
0:00 — Welcome
2:30 — Introduction
5:44 — What is a Clinical Trial?
6:59 — AL Amyloidosis Treatment Approaches Overview
17:29 — Recruiting Trials for Novel AL Therapies in 2025
18:24 — LINKER-AL2 (linvoseltamab; relapsed/refractory AL amyloidosis)
22:08 — ETENTAMIG (ABBV-383; relapsed/refractory AL amyloidosis)
25:10 — NEXICART-2 (NXC-201; relapsed/refractory AL amyloidosis)
28:26 — ALACRITY (AZD0120; relapsed/refractory AL amyloidosis)
31:36 — AT-02 (AL amyloidosis with kidney disease)
34:12 — Future Development for Novel AL Therapies
35:23 — TECLISTAMAB (BCMA-CD3; newly diagnosed AL amyloidosis)
37:22 — RAMANTAMIG (JNJ-79635322; previously treated AL amyloidosis)
39:18 — PROT-001
40:24 — Summary of Recruiting/Upcoming Studies
41:23 — News & Upcoming Milestones for Novel AL Therapies
44:03 — Other Recruiting & Planned Clinical Trials
47:10 — How to Find Clinical Trials
50:58 — Q&A Session
51:09 — Do all trials involve cardiac involvement?
52:20 — Do any trials differentiate between light chains (Kappa vs Lambda)?
NOTE: PROT-001 is being developed specifically for lambda light chain AL amyloidosis. It’s not enrolling patients yet, but when trials start in AL patients in 2026, the focus will be on patients who have increased lambda light chain levels.
52:58 — How are “primary endpoints” decided for clinical trials?
56:07 — Are clinical trials for AL different from those for ATTR?
56:59 — How are current trials different from currently approved and available treatments?
58:51 — What are some of the biggest challenges researchers face in developing new treatments for AL amyloidosis?
1:01:32 — Conclusion
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