New drug aims to clear amyloid clumps and save hearts

NCT ID NCT04512235

Ongoing Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether CAEL-101, an antibody that removes abnormal protein deposits from organs, can help people with AL amyloidosis live longer and avoid heart-related hospital stays. About 281 participants who have not yet received treatment for their plasma cell disorder will receive either CAEL-101 or a placebo, both added to standard chemotherapy. The study is active but no longer recruiting, and results are pending.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CAEL-101 (also called Anselamimab), a monoclonal antibody that removes amyloid deposits from organs
What this could lead to: If it works, this could provide a new treatment option that extends life and reduces heart-related hospitalizations for people with advanced AL amyloidosis.
What could go wrong: This is a late-stage trial, but the disease is rare and severe. The drug may not improve survival or could cause side effects. Results are not yet available.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis Immunoglobulin Light-chain Amyloidosis monoclonal gammopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AL AMYLOIDOSIS

Contacts and locations

Locations

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Scottsdale, Arizona, 85259, United States
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Duarte, California, 91010, United States
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Palo Alto, California, 94304, United States
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San Francisco, California, 94143, United States
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Jacksonville, Florida, 32224, United States
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Weston, Florida, 33331, United States
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Indianapolis, Indiana, 46202, United States
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New Orleans, Louisiana, 70112, United States
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Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02118, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48201, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Rochester, New York, 14642, United States
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Chapel Hill, North Carolina, 27599, United States
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Durham, North Carolina, 27705, United States
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Winston-Salem, North Carolina, 27157, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19104, United States
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Nashville, Tennessee, 37232, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84112, United States
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Seattle, Washington, 98109, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53226, United States
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Box Hill, 3128, Australia
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Murdoch, WA6150, Australia
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Westmead, 2145, Australia
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Woolloongabba, 4102, Australia
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Linz, 4020, Austria
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Vienna, 1090, Austria
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Anderlecht, 1070, Belgium
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Leuven, 3000, Belgium
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Porto Alegre, 90110-270, Brazil
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Ribeirão Preto, 14051-140, Brazil
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Salvador, 41253-190, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Beijing, 100034, China
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Beijing, 100730, China
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Guangzhou, 510180, China
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Hangzhou, 310009, China
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Shanghai, 200032, China
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Suzhou, 215006, China
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Wenzhou, 325000, China
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Wuhan, 430022, China
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Ostrava Poruba, 708 52, Czechia
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Prague, 12808, Czechia
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Caen, 14033, France
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Créteil, 94000, France
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Dijon, 21079, France
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Lille, 59037, France
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Limoges, 87042, France
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Marseille, 13009, France
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Paris, 75010, France
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Pessac, 33604, France
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Pierre-Bénite, 69310, France
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Poitiers, 86021, France
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Rennes, 35033, France
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Toulouse, 31100, France
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Tours, 37044, France
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Berlin, 12203, Germany
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Düsseldorf, 40225, Germany
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Essen, 45147, Germany
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Hamburg, 22767, Germany
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Heidelberg, 69120, Germany
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Würzburg, 97080, Germany
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Athens, 11528, Greece
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Rio, 26504, Greece
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Thessaloniki, 54636, Greece
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Brescia, 25123, Italy
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Fukushima, 960-1295, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa-shi, 277-8567, Japan
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Kita-ku, 603-8151, Japan
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Kumamoto, 860-8556, Japan
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Matsumoto-shi, 390-8621, Japan
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Nagoya, 467-8602, Japan
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Shibuya-ku, 150-8935, Japan
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Gdansk, 80-214, Poland
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Warsaw, 01-748, Poland
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Saint Petersburg, 197022, Russia
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Gijón, 33394, Spain
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Granada, 18014, Spain
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Madrid, 28003, Spain
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Madrid, 28040, Spain
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Majadahonda, 28222, Spain
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Pamplona, 31008, Spain
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Salamanca, 37007, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Glasgow, G12 0YN, United Kingdom
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London, NW1 2PG, United Kingdom

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