Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

Not Applicable

Recruiting

• Conditions: AL Amyloidosis
• Interventions: Drug: Teclistamab (Tec)

• Registration Number: NCT06699394
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-21
• Study Start: 2025-03-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	Teclistamab (Tec)	Teclistamab monotherapy

Primary Outcome Measures

Name	Time	Method
Complete hematological response	3 months, 6 months	Complete hematological response using ISA criteria

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Peking University Peoples Hospital; 🇨🇳 Beijing, Beijing, China

Fuxing Hospital affiliated to Capital Medical University; 🇨🇳 Beijing, China