Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

NCT ID: NCT06699394

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-29
• Study Completion Date: 2026-12-31

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.

Detailed Description

The treatment of amyloidosis should focus more on complete hematological response (CHR) and organ response rate. We hypothesize that teclistamab can deeply eliminate cloned plasma cells in AL patients, achieving a high proportion of complete hematological response.

In clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14)）have been used, the outcome is poor. Also, CHR is correlated with better clinical outcomes. In clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells.

To further explore efficacy and safety, we designed this prospective study.

Conditions

AL Amyloidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Teclistamab monotherapy

Group Type: OTHER

Teclistamab (Tec)

Intervention Type: 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.

Interventions

Teclistamab (Tec)

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of systemic AL amyloidosis;

2. 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;

3. Life expectancy greater than 12 weeks;

4. HGB ≥70g/L;

5. Blood oxygen saturation > 90%;

6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;

7. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.

2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;

3. Severe or persistent infection that cannot be effectively controlled;

4. Presence of severe autoimmune diseases or immunodeficiency disease;

5. Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);

6. Patients with HIV infection or syphilis infection;

7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Lu, MD

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Lu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Fuxing Hospital affiliated to Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Dr, M.D.

Role: CONTACT

pkuphliuyang@bjmu.edu.cn

+86-10-88326542

Facility Contacts

Yang Liu, Dr

Role: primary

pkuphliuyang@bjmu.edu.cn

86-13716926210

Liru Wang

Role: primary

wanglirumail@126.com

010-18618238652

Other Identifiers

2023PHB319-001-03

Identifier Type: -

Identifier Source: org_study_id