Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07079423

Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Led by Peking Union Medical College Hospital · Updated on 2025-07-23

35

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab

CONDITIONS

Official Title

Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy confirmed AL amyloidosis
  • Mayo 2004 stage IIIB
  • Difference in involved and uninvolved free light chains (dFLC)  50 mg/L
Not Eligible

You will not qualify if you...

  • Uncontrolled infection
  • Other active malignancy
  • Diagnosis of multiple myeloma or Waldenstrom macroglobulinemia
  • Grade 2 Mobitz II or grade 3 atrioventricular block unless with implanted pacemaker
  • Sustained or recurrent nonsustained ventricular tachycardia
  • Positive for human immunodeficiency virus
  • Hepatitis B virus (HBV)-DNA over 1000 copies/mL
  • Positive for hepatitis C unless sustained virologic response
  • Low blood counts: neutrophils <1 x 10^9/L, hemoglobin <8 g/dL, or platelets <75 x 10^9/L
  • Severely compromised liver or kidney function: ALT or AST > 5 times upper normal limit, total bilirubin > 2 times upper normal limit, estimated glomerular filtration rate < 20 mL/min, or receiving renal replacement therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China, 100730

Actively Recruiting

Loading map...

Research Team

K

Kaini Shen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis | DecenTrialz