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NCT06935162RecruitingPhase 2

Teclistamab in Previously Treated AL Amyloidosis

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

Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
11 Apr 2025
Start date
21 May 2025
Primary completion date
31 Dec 2026
Lead sponsor
Peking Union Medical College Hospital
Diseases
Amyloidosis
NCT number
NCT06935162

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 21 May 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous anti-BCMA targeted therapy

Other illness

  • Co-morbidity of uncontrolled infection
  • Co-morbidity of other active malignancy
  • Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response)

Lab values

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.