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RecruitingNCT06699394Updated Apr 24, 2025

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

An interventional study of Teclistamab (Tec) in AL Amyloidosis, sponsored by Peking University People's Hospital. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • AL Amyloidosis

Keywords

  • teclistamab
  • complete hematological response
03

In context

Immunoglobulin Light-chain Amyloidosis

167 studies on the registry are indexed under Immunoglobulin Light-chain Amyloidosis; 57 are open to participants now.

This study's planned enrollment of 20 is below the median of 37 across 120 interventional studies indexed under Immunoglobulin Light-chain Amyloidosis.

Browse Immunoglobulin Light-chain Amyloidosis studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Group 1

    Teclistamab monotherapy

    Drug: Teclistamab (Tec)

Interventions

  • DrugTeclistamab (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.

06

What researchers measure

Primary outcomes

  1. Complete hematological response

    Complete hematological response using ISA criteria

    Time frame: 3 months, 6 months

Secondary outcomes

  1. Minimal residual disease

    Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10\^-5.

    Time frame: 3 months, 6 months

  2. Stringent dFLC response

    dFLC ≤ 10 mg/L

    Time frame: 3 months, 6 months

  3. TRAE

    Treatment realted adverse events

    Time frame: 3 months, 6 months, 12 months

  4. 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.

    Time frame: 12 months, 24 months

  5. OS

    Overall survival

    Time frame: 12 months, 24 months

  6. Renal Response

    Renal Response according to ISA criteria

    Time frame: 3 months, 6 months, 12 months

  7. Cardiac Response

    Cardiac Response according to ISA criteria

    Time frame: 3 months, 6 months, 12 months

  8. Hepatic Response

    Hepatic Response according to ISA criteria

    Time frame: 3 months, 6 months, 12 months

07

Study locations

2 of 2 sites recruiting
  • Peking University Peoples Hospital
    Beijing, Beijing 100044, China
    Recruiting
  • Fuxing Hospital affiliated to Capital Medical University
    Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06699394
Lead sponsor
Peking University People's Hospital
Responsible party
Jin Lu, MD (Dr, Peking University) — Principal investigator
First posted
Nov 21, 2024
Start date
Mar 29, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 24, 2025

Study contacts

Yang Dr, M.D.
Contact
pkuphliuyang@bjmu.edu.cn
+86-10-88326542
Jin Lu, M.D.
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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