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NCT Number: NCT06935162

Teclistamab in Previously Treated AL Amyloidosis

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Kaini Shen

CONTACT

[email protected]

86+13693339884

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teclistamab (Tec)

Drug

Teclistamab will be administered via a subcutaneous injection

Primary outcomes

  1. Hematologic complete response (CR) at 3 months after treatment initiation

    Time frame: at 3 months after treatment initiation

Study contacts

Contact information is provided by the study sponsor or research team.

Kaini Shen

CONTACT

[email protected]

86-13693339884

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 20, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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