Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: AL Amyloidosis
• Intervention / Treatment: Drug: Teclistamab (Tec)

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Dr, M.D.; Phone Number: +86-10-88326542; Email: pkuphliuyang@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fuxing Hospital affiliated to Capital Medical University
    • Contact: Liru Wang; Phone Number: 010-18618238652; Email: wanglirumail@126.com
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University Peoples Hospital
      • Contact: Yang Liu, Dr; Phone Number: 86-13716926210; Email: pkuphliuyang@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Teclistamab monotherapy	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete hematological response	Complete hematological response using ISA criteria	3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal residual disease	Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10^-5.	3 months, 6 months
Stringent dFLC response	dFLC ≤ 10 mg/L	3 months, 6 months
TRAE	Treatment realted adverse events	3 months, 6 months, 12 months
MOD-PFS	The time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occurs first.	12 months, 24 months
OS	Overall survival	12 months, 24 months
Renal Response	Renal Response according to ISA criteria	3 months, 6 months, 12 months
Cardiac Response	Cardiac Response according to ISA criteria	3 months, 6 months, 12 months
Hepatic Response	Hepatic Response according to ISA criteria	3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Jin Lu, M.D., Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: teclistamab; complete hematological response
• Additional Relevant MeSH Terms: Neoplasms; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Paraproteinemias; Proteostasis Deficiencies; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
• Other Study ID Numbers: 2023PHB319-001-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No