Study of Teclistamab for Patients with Previously Treated AL Amyloidosis

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What is this study about?

This clinical trial is focused on studying a condition known as Immunoglobulin Light-Chain (AL) Amyloidosis. This is a disease where abnormal proteins, called amyloids, build up in organs and tissues, affecting their normal function. The trial will use a treatment called teclistamab, which is a solution for injection. Teclistamab is a type of medication known as a BiTE, or bispecific T-cell engager, which is designed to help the immune system target and destroy abnormal cells.

The purpose of the study is to evaluate how well teclistamab works in patients who have previously been treated for AL amyloidosis. Participants will receive teclistamab injections under the skin over a period of time. The study will monitor the response of the disease to the treatment after three cycles, which are periods of treatment followed by rest. The study will also look at how long the response lasts, how the organs affected by the disease respond, and the overall safety and tolerability of the treatment.

Throughout the study, participants will be regularly assessed to see how their condition is responding to the treatment. This includes checking for any changes in their health and any side effects they might experience. The study aims to provide valuable information on the effectiveness and safety of teclistamab for people with AL amyloidosis, potentially leading to better treatment options in the future.

1 joining the trial

Upon joining the trial, you will begin the process of receiving treatment for immunoglobulin light-chain (AL) amyloidosis.

The trial involves the administration of a medication called teclistamab, which is given as a solution for injection under the skin, known as subcutaneous use.

2 treatment cycles

The treatment is organized into cycles. Each cycle lasts for a specific period, during which you will receive the medication.

The main goal is to assess the response of your condition after 3 cycles of receiving teclistamab.

3 medication administration

You will receive the medication teclistamab through an injection under the skin.

The frequency and dosage of the medication will be determined by the medical team overseeing the trial.

4 monitoring and assessments

Throughout the trial, your health and response to the medication will be closely monitored.

Regular assessments will be conducted to evaluate the effectiveness of the treatment and to ensure your safety.

5 completion of cycles

After completing 3 cycles of treatment, the primary outcome will be assessed to determine the response of your condition.

Additional assessments may occur at the completion of 1, 3, and 6 cycles, and every 3 months thereafter, to monitor ongoing response and health status.

6 end of trial participation

Your participation in the trial will continue until the trial’s end date or until it is determined that you should no longer receive the treatment.

The estimated end date for the trial is March 31, 2028.

Who Can Join the Study?

Must have a confirmed diagnosis of AL amyloidosis, which is a condition where abnormal proteins build up in tissues and organs. This diagnosis should be confirmed through specific tests like immunohistochemistry, immunofluorescence, immunoelectron microscopy, or mass spectrometry.
Genetic testing must show no mutations related to hereditary amyloidosis, or tests must clearly show specific light chains (types of proteins) if the main symptoms are in the nerves or heart.
Must be at least 18 years old.
Must have an ECOG performance status of 0, 1, or 2, which means the patient is fully active or has some symptoms but can take care of themselves.
Must have Mayo stage I-IIIA cardiac disease, which refers to specific stages of heart involvement in amyloidosis.
If the patient has relapsed, they must have had at least one previous treatment, including specific drugs like Dara and bortezomib, and must have completed at least two cycles of therapy.
Must have measurable disease, which means certain blood tests show specific levels of proteins or a monoclonal spike, indicating the presence of the disease.
Must have symptoms in at least one organ, such as the heart, kidneys, liver, digestive system, or nerves.
Must not have received any treatment for AL amyloidosis for at least 14 days before starting this trial.

Who Cannot Join the Study?

Patients who have not been previously treated for Immunoglobulin Light-Chain (AL) Amyloidosis cannot participate. This condition involves abnormal proteins that can build up in organs and tissues.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age categories.
Patients who are not part of the specified clinical trial groups cannot participate. These groups are defined by the study.
Patients who are not female or male subjects as specified by the study cannot participate.
Patients who are not part of the vulnerable population selected for the study cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Alexandra Hospital	Athens	Greece
Uswuccounoibwhadhptqo Ekglj Auc	Essen	Germany
Cpzywp Hezfqhtbmaa Ec Uyupndrxfdiix Dw Levfmzr	Limoges	France
Azbxiaqpak Pzmqyini Hnuhhiwz Dy Pcxjv	Paris	France
Uusuavodsopteemddfstz Wstjkfqro Aru	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.03.2025
Germany	Not recruiting	31.03.2025
Greece	Not recruiting	31.03.2025
Italy	Not recruiting	31.03.2025
The Netherlands	Not recruiting	31.03.2025

Trial locations

Investigated drugs:

Teclistamab

Teclistamab is a medication being studied for its potential to help people with a condition called AL amyloidosis, which is a disease where abnormal proteins build up in tissues and organs. This medication works by targeting specific cells in the immune system to help reduce the amount of these abnormal proteins. In this trial, researchers are looking at how well teclistamab can help improve the health of patients who have already received other treatments for their condition. The goal is to see if teclistamab can help achieve a complete response, meaning the disease is no longer detectable, after three cycles of treatment. This medication is given as a single agent, which means it is used alone without combining it with other treatments.

Investigated diseases:

Primary amyloidosis

Immunoglobulin Light-Chain (AL) Amyloidosis – This disease is characterized by the abnormal deposition of amyloid proteins, which are derived from immunoglobulin light chains, in various tissues and organs. The accumulation of these proteins can disrupt normal organ function. Commonly affected organs include the heart, kidneys, liver, and nervous system. As the disease progresses, it can lead to organ dysfunction, such as heart failure or kidney damage. Symptoms vary depending on the organs involved and may include fatigue, weight loss, swelling, and numbness. The progression of the disease is influenced by the extent and location of amyloid deposits.

Trial ID:

2024-519191-90-00

Protocol code:

EMN40

NCT ID:

NCT06649695

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Teclistamab for Patients with Previously Treated AL Amyloidosis

What is this study about?

Who Can Join the Study?

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