Who may be eligible for the Teclistamab-Daratumumab in AL Amyloidosis trial?

Inclusion Criteria: 1. Age \>18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf. 2. Ability to comply with the study protocol, in the investigator's judgment. 3. Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red. 4. Patient must not have received any prior plasma cell clone-directed therapy. 5. Measurable hematologic disease, defined as one of the following: 1. Difference between involved and uninvolved serum free light chain (dFLC) ≥50 mg/L and/or 5 mg/dL 2. Serum M-protein ≥0.5 g/dL on protein electrophoresis 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. One or more organs involved by AL amyloidosis as per consensus guidelines 8. Pre-treatment clinical laboratory values meeting the following criteria during the screening phase: 1. Absolute neutrophil count ≥0.75 × 10\^9/L 2. Hemoglobin level ≥8.0 g/dL; red blood cell transfusion allowed until 7 days before C1D0. 3. Platelet count ≥50 × 10\^9/L; Platelet transfusions are acceptable without restriction during the Screening period 4. Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN) 5. Aspartate aminotransferase (AST) ≤2.5 times the ULN 6. Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN 7. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m\^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs. For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm. Exclusion Criteria: 1. Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0. 2. Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET/CT) (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, (d) Bone marrow plasma cell infiltrate of greater than 60%. Patients with involved/uninvolved serum FLC ratio\>100 as the sole myeloma-defining event will be allowed. 3. Evidence of significant cardiovascular conditions as specified below: 1. NT-Pro BNP \> 8500 pg/mL, and/or 2. NYHA Class IIIb or IV functional class 4. History of other malignancy that could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment. 5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal). 6. Patients on renal replacement therapy 7. Patients with HIV who are not on HAART or those with active hepatitis A, B, or C infection. 8. Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted, as per investigators' discretion. 9. Known hypersensitivity to any of the agents 10. Patients who are receiving any other investigational agent concurrently.

ClinicalTrials.gov record NCT07110844

Teclistamab-Daratumumab in AL Amyloidosis

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

A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis

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 to 100 years old

SexAll

LocationUnited States

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 2 study gives teclistamab plus daratumumab to adults with newly diagnosed (previously untreated) AL amyloidosis. All participants receive the combination in 28-day treatment cycles for about six months. The main outcome measured is hematologic complete response at 6 months; the study also tracks safety and organ-related outcomes. Follow-up includes tests for minimal residual disease, organ responses, adverse events such as cytokine release syndrome and infections, and survival up to 18 months.

What it is studying. The study assesses the effectiveness and safety of combining teclistamab with daratumumab in adults with newly diagnosed AL amyloidosis. It focuses on whether the combination reduces toxic amyloid-producing light chains (measured as hematologic complete response at 6 months) and on measures of minimal residual disease, organ responses, treatment-related complications, and survival.

What the researchers hope to learn. Scientific goals: measure the hematologic complete response rate at 6 months, rates of minimal residual disease negativity, organ (heart, kidney, liver) response and progression, frequency of cytokine release syndrome and infections, a major organ deterioration–progression-free survival metric, and overall survival up to 18 months.

What this study is about

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

The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.

Interventions being studied

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

Drug: Teclistamab
Daratumumab and Hyaluronidase-fihj

Eligibility

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

Inclusion criteria

Age >18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf.
Ability to comply with the study protocol, in the investigator's judgment.
Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.
Patient must not have received any prior plasma cell clone-directed therapy.
Measurable hematologic disease, defined as one of the following:
Difference between involved and uninvolved serum free light chain (dFLC) ≥50 mg/L and/or 5 mg/dL
Serum M-protein ≥0.5 g/dL on protein electrophoresis
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
One or more organs involved by AL amyloidosis as per consensus guidelines
Pre-treatment clinical laboratory values meeting the following criteria during the screening phase:
Absolute neutrophil count ≥0.75 × 10\^9/L
Hemoglobin level ≥8.0 g/dL; red blood cell transfusion allowed until 7 days before C1D0.
Platelet count ≥50 × 10\^9/L; Platelet transfusions are acceptable without restriction during the Screening period
Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN)
Aspartate aminotransferase (AST) ≤2.5 times the ULN
Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN
Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m\^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs.
For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion criteria

Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.
Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET/CT) (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, (d) Bone marrow plasma cell infiltrate of greater than 60%.
Patients with involved/uninvolved serum FLC ratio>100 as the sole myeloma-defining event will be allowed.
Evidence of significant cardiovascular conditions as specified below:
NT-Pro BNP > 8500 pg/mL, and/or
NYHA Class IIIb or IV functional class
History of other malignancy that could affect compliance with the protocol or interpretation of results.
Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal).
Patients on renal replacement therapy
Patients with HIV who are not on HAART or those with active hepatitis A, B, or C infection.
Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted, as per investigators' discretion.
Known hypersensitivity to any of the agents
Patients who are receiving any other investigational agent concurrently.

Study description and what participation involves

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

Detailed description from the registry

The purpose of this study is to assess the effectiveness and safety of teclistamab-daratumumab combination in newly diagnosed AL amyloidosis. The study aims to evaluate whether this combination is able to effectively decrease the level of toxic amyloid-producing light chains circulating in the participants' blood, with the overarching goal of avoiding organ damage, improving organ function, and prolonging life.

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 plus daratumumab in 28‑day cycles, with treatment expected to last about 6 months. They will attend regular clinic visits for drug dosing and safety monitoring, including frequent checks early in treatment for cytokine‑release syndrome and infections. Tests include blood samples (for free light chains and other labs), organ‑function assessments (heart, kidney, liver) and bone marrow biopsy to assess minimal residual disease. There is an end‑of‑treatment visit and follow‑up visits for outcomes and survival monitoring up to about 18 months; stem‑cell collection during the first 6 cycles may be permitted by the investigator.

How the study is structured. Phase 2, interventional, single-group (all participants receive the same treatment), open-label. Treatment is given in 28-day cycles for an expected treatment period of about six months, with clinical and laboratory assessments during treatment and follow-up visits out to 18 months. Assessments include blood tests, bone marrow testing for minimal residual disease, and monitoring of heart, kidney, and liver measures and adverse events.

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 United States. 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: Nov 7, 2025
Primary completion: October 2031 (estimated)
Study completion: October 2033 (estimated)
Target enrollment: 25 participants (estimated)
Last updated on registry: Nov 19, 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: Suzanne Lentzsch, MD
Collaborators: Janssen Pharmaceuticals

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.

Central Nurse Navigator, RN 📞 (212) 342 5162 ✉ cancerclinicaltrials@cumc.columbia.edu

Participating sites (1)

Columbia University Irving Medical CenterRecruiting
New York, New York, 10032 · United States
- Research Nurse Navigator, RN · 646-317-4840 · cancerclinicaltrials@cumc.columbia.edu
- Suzanne Lentzsch, MD, PhD
- Rajshekhar Chakraborty, MD

Terms used on this page · explanations by MedicalUpdates.ai

Informed Consent Form: 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.
legally authorized representative: A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
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.
serum free light chain: Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
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.
ECOG: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Absolute neutrophil count: The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
Screening period: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
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.
Estimated glomerular filtration rate: A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
women of childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Prior therapy: Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
corticosteroid: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
CT: An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
PET/CT: A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
stem cell transplant: A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
investigational agent: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
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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