Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

NCT07079423 | Recruiting Phase 2

• 1 other identifier: TEC-IIIB AL
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

AL Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation

  Stringent dFLC response is defined as dFLC \< 10 mg/L or involved free light chain (FLC) ≤ 20 mg/L, and FLC will be tested using FreeLite assay (Binding Site).

  at 1 months after treatment initiation

Study Arms (1)

Teclistamab

EXPERIMENTAL

Teclistamab will be administered via a subcutaneous injection

Drug: Teclistamab (Tec)

Interventions

Teclistamab (Tec) DRUG

Teclistamab will be administered via a subcutaneous injection

Teclistamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy confirmed AL amyloidosis
• Mayo 2004 stage IIIB
• dFLC ≥ 50mg/L

You may not qualify if:

• 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, estimated glomerular filtration rate \< 20 mL/min, or receiving renal replacement therapy

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Interventions

Focal Adhesion Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Kaini Shen

CONTACT

86-13693339884; shenkaini3@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 23, 2025
• Study Start: June 28, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

CN (1)