New drug combo aims to wipe out rare blood disease
NCT ID NCT07110844
First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times
Summary
This study tests whether two drugs, teclistamab and daratumumab, can safely and effectively treat AL amyloidosis, a rare disease where abnormal proteins damage organs. The treatment lasts about 6 months. Researchers will check if the drugs can make the abnormal proteins disappear from the blood. The study is for people who have not received prior treatment for this condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Boston Medical Center
NOT_YET_RECRUITINGBoston, Massachusetts, 02118, United States
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
Contact Email: •••••@•••••
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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