Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

NCT06699394 | Recruiting

• 1 other identifier: 2023PHB319-001-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.

Conditions

AL Amyloidosis

Keywords

teclistamab; complete hematological response

Outcome Measures

Primary Outcomes (1)

• Complete hematological response

  Complete hematological response using ISA criteria

  3 months, 6 months

Secondary Outcomes (8)

• Minimal residual disease

  3 months, 6 months

• Stringent dFLC response

  3 months, 6 months

• TRAE

  3 months, 6 months, 12 months

• MOD-PFS

  12 months, 24 months

• OS

  12 months, 24 months

Study Arms (1)

Group 1

OTHER

Teclistamab monotherapy

Drug: Teclistamab (Tec)

Interventions

Teclistamab (Tec) DRUG

Teclistamab is administered subcutaneously with higher step-up doses (SUDs). Patients receive teclistamab with SUDs: 0.2 and 0.7 mg/kg and 1.5 mg/kg in Cycle 1 (2-4 days between doses). 3 mg/kg every 4 weeks will be used in subsequent cycles.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of systemic AL amyloidosis;
• Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;
• Life expectancy greater than 12 weeks;
• HGB ≥70g/L;
• Blood oxygen saturation \> 90%;
• Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
• Informed consent explained to, understood by and signed by the patient.

You may not qualify if:

• Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
• Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
• Severe or persistent infection that cannot be effectively controlled;
• Presence of severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
• Patients with HIV infection or syphilis infection;
• Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (2)

Peking University Peoples Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Fuxing Hospital affiliated to Capital Medical University

Beijing, 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

Study Officials

• Jin Lu, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Dr, M.D.

CONTACT

+86-10-88326542; pkuphliuyang@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: March 29, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)