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RecruitingNCT06935162Updated May 25, 2025

Teclistamab in Previously Treated AL Amyloidosis

A Phase 2 interventional study of Teclistamab (Tec) in AL Amyloidosis, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

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Conditions studied

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In context

Immunoglobulin Light-chain Amyloidosis

167 studies on the registry are indexed under Immunoglobulin Light-chain Amyloidosis; 57 are open to participants now.

This study's planned enrollment of 30 is below the median of 37 across 120 interventional studies indexed under Immunoglobulin Light-chain Amyloidosis.

Browse Immunoglobulin Light-chain Amyloidosis studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Teclistamab

    Teclistamab will be administered via a subcutaneous injection

    Drug: Teclistamab (Tec)

Interventions

  • DrugTeclistamab (Tec)

    Teclistamab will be administered via a subcutaneous injection

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What researchers measure

Primary outcomes

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

    Time frame: at 3 months after treatment initiation

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Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06935162
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Jian Li (Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Apr 20, 2025
Start date
May 21, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 25, 2025

Study contacts

Kaini Shen
Contact
shenkaini3@sina.com
86-13693339884

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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