Who may be eligible for the Teclistamab in Previously Treated AL Amyloidosis trial?

Inclusion Criteria: * Biopsy confirmed AL amyloidosis * Patients must have received at least one line of treatment, including daratumumab and bortezomib * Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment * dFLC \> 50mg/L Exclusion Criteria: * Previous anti-BCMA targeted therapy * Co-morbidity of uncontrolled infection * Co-morbidity of other active malignancy * Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia * Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker) * Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia * Seropositive for human immunodeficiency virus * Hepatitis B virus (HBV)-DNA \> 1000 copies/mL * Seropositive for hepatitis C (except in the setting of a sustained virologic response) * Neutrophil \ 5 × upper limit of normal (ULN), total bilirubin \> 2 × ULN, eGFR \< 20 mL/min, or receiving renal replacement therapy

ClinicalTrials.gov record NCT06935162

Teclistamab in Previously Treated AL Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old and older

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase II study tests subcutaneous teclistamab in people with previously treated immunoglobulin light-chain (AL) amyloidosis. It is a single-group, open-label trial that evaluates hematologic response and safety. The primary outcome is hematologic complete response measured at three months after starting treatment.

What it is studying. The study tests subcutaneous teclistamab given to people with previously treated immunoglobulin light-chain (AL) amyloidosis, measuring hematologic complete response at three months and monitoring safety.

What the researchers hope to learn. To evaluate the efficacy and safety of subcutaneous teclistamab in people with previously treated AL amyloidosis, with hematologic complete response at three months as the primary scientific outcome.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Teclistamab (Tec)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Biopsy confirmed AL amyloidosis
Patients must have received at least one line of treatment, including daratumumab and bortezomib
Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment
dFLC > 50mg/L

Exclusion criteria

Previous anti-BCMA targeted therapy
Co-morbidity of uncontrolled infection
Co-morbidity of other active malignancy
Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
Seropositive for human immunodeficiency virus
Hepatitis B virus (HBV)-DNA > 1000 copies/mL
Seropositive for hepatitis C (except in the setting of a sustained virologic response)
Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L.
Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) > 5 × upper limit of normal (ULN), total bilirubin > 2 × ULN, eGFR < 20 mL/min, or receiving renal replacement therapy

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive teclistamab given by subcutaneous injection. They will attend clinic visits for monitoring and tests to measure hematologic response (the primary outcome is hematologic complete response at 3 months) and to check safety. The registry record does not list other specific procedures, visit schedules, or additional invasive tests.

How the study is structured. Interventional Phase II treatment study. All participants receive subcutaneous teclistamab in a single, non-randomized, open-label group (no placebo or blinding). Participants are followed to measure blood response (hematologic complete response at three months) and adverse effects.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 21, 2025
Primary completion: Dec 31, 2026 (estimated)
Study completion: Dec 31, 2028 (estimated)
Target enrollment: 30 participants (estimated)
Last updated on registry: May 25, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Peking Union Medical College Hospital
Principal investigator: Jian Li, Professor
Peking Union Medical College Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Kaini Shen 📞 86-13693339884 ✉ shenkaini3@sina.com

Participating sites (1)

Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, 100730 · China
- Kaini Shen · 86+13693339884 · shenkaini3@sina.com

Terms used on this page · explanations by MedicalUpdates.ai

Biopsy: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Relapse: A condition that improved with treatment and has since returned or worsened.
very good partial response: A response category used in some blood conditions meaning the disease marker has fallen a great deal but not disappeared. The exact definition depends on the condition and the study.
dFLC: The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
upper limit of normal: The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
eGFR: A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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