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Blood & Immune

Light Chain Amyloidosis Clinical Trials and Treatments

Also called AL Amyloidosis, Primary Amyloidosis, Systemic Light Chain Amyloidosis

Light Chain Amyloidosis results from clonal plasma cell proliferation producing excessive amounts of misfolded immunoglobulin light chains (kappa or lambda) that cannot be properly degraded. These misfolded proteins aggregate to form amyloid fibrils that deposit in various tissues, causing progressive organ dysfunction.

In plain words, light chain amyloidosis is a rare blood disorder where certain blood cells make faulty proteins that clump together. These clumps collect in the heart and kidneys as well as nerves and other organs, slowly making it harder for them to work.

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Light Chain Amyloidosis

Where treatments stand, from ClinicalTrials.gov and FDA labels

FDA review0

No decision pending. FDA calendar

FDA-approved medicines1

Darzalex Faspro

Light Chain Amyloidosis has 1 FDA-approved medicine, 48 open or active clinical trials, and no pending FDA decision.

Labels checked October 21, 2026. Corticosteroids and immune globulins count once each.Download the data

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More about Light Chain Amyloidosis

The heart is affected in approximately 50-70% of patients, leading to restrictive cardiomyopathy with diastolic dysfunction, arrhythmias, and sudden cardiac death. Renal involvement occurs in 40-50% of patients, presenting as nephrotic syndrome with heavy proteinuria. Peripheral neuropathy develops in approximately 10-15% of patients, ranging from small fiber neuropathy to autonomic dysfunction. Other affected organs include liver, eyes, gastrointestinal tract, and soft tissues.

Keep reading about Light Chain Amyloidosis

The underlying plasma cell clone is usually modest in size and may not meet criteria for multiple myeloma. Early diagnosis is critical, as untreated disease rapidly progresses to multi-organ failure. Median survival without treatment is approximately 2-4 years when cardiac involvement is present.

What are the symptoms of Light Chain Amyloidosis?

These are common symptoms of Light Chain Amyloidosis, and how strong they are varies from person to person.

  • Fatigue and weakness
  • Shortness of breath and heart failure symptoms
  • Swelling in ankles, feet, legs, and abdomen (edema)
  • Numbness, tingling, or pain in hands and feet (peripheral neuropathy)
  • Proteinuria (protein in urine) and kidney dysfunction
  • Unexplained weight loss

Who gets Light Chain Amyloidosis?

Light Chain Amyloidosis typically affects older adults, with median age of diagnosis around 63 years, though younger patients can be affected. It affects males more frequently than females. The disease occurs across all racial and ethnic groups. It predominantly affects individuals of European ancestry, though increasing recognition in other populations suggests possible underdiagnosis.

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Which medicines are FDA-approved for Light Chain Amyloidosis?

There is currently 1 FDA-approved medication for Light Chain Amyloidosis.

daratumumab and hyaluronidase-fihj
Janssen Biotech (Johnson & Johnson)
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

How to get help paying for Light Chain Amyloidosis treatment

Charity funds and drugmaker programs for Light Chain Amyloidosis, checked at the source.

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Charity funds
  • From a charity · TotalAssist (formerly PAN Foundation)
    Amyloidosis fund
    Open

    Pays for: Out-of-pocket costs for approved medications, up to $5,500 per year. Requires Medicare, Medicaid or TRICARE.

  • From a charity · NORD RareCare
    Amyloidosis Medical Assistance fund
    Waitlist

    Pays for: Medical and medication costs.

    The foundation says: “Temporarily Waitlisting”
  • From a charity · NORD RareCare
    Amyloidosis Premium Copay Assistance fund
    Waitlist

    Pays for: Insurance premiums and copays.

    The foundation says: “Temporarily Waitlisting”
  • From a charity · The Assistance Fund
    Amyloidosis fund
    Waitlist

    Pays for: Copays, coinsurance, deductibles and other health-related expenses.

Status as each foundation showed it on October 26, 2026.
Drugmaker programs
Open a medicine for who qualifies, by insurance type.

Every program and fund for Light Chain Amyloidosis, by insurance →

Side effects people have reported to the FDA

Side effects people have reported to the FDA

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Diagnosis and genetic testing

Genetic testing for Light Chain Amyloidosis

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted Light Chain Amyloidosis resources

Reputable organizations and medical references for learning more about Light Chain Amyloidosis, including disease registries, foundation resources, and clinical guidelines.

Active clinical trials for Light Chain Amyloidosis

Use this Light Chain Amyloidosis clinical trial finder to see the 17 studies recruiting patients and 3 not yet recruiting in the United States and worldwide, with eligibility criteria in plain English. Of these, 17 test a treatment and 3 are observational studies or registries; each card says which. Every trial comes from ClinicalTrials.gov.

Jump to the trial list, the site map or the pipeline timeline.

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

48 active trials worldwide
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RecruitingTreatment trialPhase 1Recently updatedNCT07250269

Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis

Intervention: GC012F Injection

Sponsor: Gracell Biotechnologies (Shanghai) Co., Ltd.

This is a Phase 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.

Ages 18 Years+
Started Oct 2025Updated 1 week agoEst. Nov 2028 (~2 years)
RecruitingTreatment trialPhase 2Recently updatedNCT06971380

Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis

Intervention: HBI0101 CART

Sponsor: Polina Stepensky

A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to evaluate the efficacy and safety of HBI0101 CART.

Ages 18 Years+1 location
Started Mar 2025Updated 1 week agoEst. May 2028 (~1y 6m)
RecruitingTreatment trialPhase 1Recently updatedNCT05652335

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Intervention: JNJ-79635322

Sponsor: Janssen Research & Development, LLC

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

Ages 18 Years+
Started Nov 2022Updated 1 week agoEst. Apr 2027 (~5 months)
Not yet recruitingTreatment trialEarly Phase 1Recently updatedNCT07615270

A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement

Intervention: Anselamimab

Sponsor: Stanford University

This is an exploratory study to assess the binding of CAEL-101/anselamimab to amyloid in vivo, recruitment of inflammatory cells and reduction of the amyloid mass.

Ages 18 Years+1 location
Expected to start Sep 2026Updated 2 weeks agoEst. Jul 2028 (~1y 8m)
Not yet recruitingTreatment trialPhase 1Recently updatedNCT07874334

Phase 1a/b Study of GPRC5D CART Therapy in Relapsed/Refractory Multiple Myeloma and Light-chain Amyloidosis

Intervention: GPRC5D CART

Sponsor: Hadassah Medical Organization

A Phase 1a/b Open-Label Study to Evaluate Safety and Preliminary Efficacy of GPRC5D CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma and Light-chain Amyloidosis.

Ages 18 Years+1 location
Expected to start Nov 2026Updated 3 weeks agoEst. Dec 2032 (~6y 1m)
Find Light Chain Amyloidosis trials near you, ranked by distance →
Active trial locations106 cities in the US
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Trial Pipeline

Jan 2021 to Nov 2031
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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
Always talk to your doctor before considering a clinical trial.

Light Chain Amyloidosis patient communities

Facebook groups, Reddit communities and YouTube channels where Light Chain Amyloidosis patients, caregivers and advocacy groups talk.

Companies developing Light Chain Amyloidosis treatments

Drugmakers that list Light Chain Amyloidosis in their rare disease portfolio, 8 in all.

Questions people ask about Light Chain Amyloidosis