ClinicalTrials.gov record NCT06699394

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

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

Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study

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.
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 single-arm, prospective, multi-center study gives teclistamab alone to people with systemic AL amyloidosis who previously received daratumumab and bortezomib and have not achieved a complete hematological response. Teclistamab is given subcutaneously with higher step-up doses in the first cycle (0.2, 0.7, 1.5 mg/kg, spaced 2–4 days) and then 3 mg/kg every 4 weeks in later cycles. The study measures hematological and marrow responses, organ responses, safety, and survival at planned time points.

What it is studying. The study tests teclistamab monotherapy to see if it can produce complete hematological responses in systemic AL amyloidosis and assesses safety, minimal residual disease in bone marrow, organ responses, and survival outcomes.

What the researchers hope to learn. Primary scientific goals are to measure complete hematological response rate (using ISA criteria) at 3 and 6 months; assess bone marrow minimal residual disease; record organ responses (renal, cardiac, hepatic); document treatment-related adverse events; and estimate progression-free and overall survival.

What this study is about

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

This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.

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

  • Diagnosis of systemic AL amyloidosis;
  • Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;
  • Life expectancy greater than 12 weeks;
  • HGB ≥70g/L;
  • Blood oxygen saturation > 90%;
  • Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
  • Informed consent explained to, understood by and signed by the patient.

Exclusion criteria

  • Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
  • Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
  • Severe or persistent infection that cannot be effectively controlled;
  • Presence of severe autoimmune diseases or immunodeficiency disease;
  • Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
  • Patients with HIV infection or syphilis infection;
  • Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The treatment of amyloidosis should focus more on complete hematological response (CHR) and organ response rate. We hypothesize that teclistamab can deeply eliminate cloned plasma cells in AL patients, achieving a high proportion of complete hematological response. In clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14)）have been used, the outcome is poor. Also, CHR is correlated with better clinical outcomes. In clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells. To further explore efficacy and safety, we designed this prospective study.

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 will receive subcutaneous teclistamab with step-up doses in Cycle 1 (0.2, 0.7 and 1.5 mg/kg given 2–4 days apart) and then 3 mg/kg every 4 weeks in later cycles. They will attend regular clinic visits for safety checks, blood tests and response assessments (outcomes are measured at 3, 6, 12 and 24 months in the record). Bone marrow testing for minimal residual disease will be performed (requires a bone marrow sample). Participants must give informed consent and will be monitored for treatment-related adverse events.

How the study is structured. An interventional, open-label, single-group (no control) study. Participants receive subcutaneous teclistamab with step-up dosing in Cycle 1 and ongoing doses every 4 weeks; investigators follow participants for response and adverse events at scheduled times (including 3, 6, 12, and 24 months).

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
Mar 29, 2025
Primary completion
Dec 31, 2025 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
20 participants (estimated)
Last updated on registry
Apr 24, 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 University People's Hospital
Principal investigator
Jin Lu, MD, Dr
Peking University

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.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
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.
Informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
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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