AL AmyloidosisNCT06699394
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
A study testing Teclistamab (Tec) in people with AL Amyloidosis, run by Peking University People's Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AL Amyloidosis
- What is being tested?
- Teclistamab (Tec)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 29 Mar 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044
Yang Liu, Dr, 86-13716926210, pkuphliuyang@bjmu.edu.cn
- Recruiting
Fuxing Hospital affiliated to Capital Medical University
Beijing
Liru Wang, 010-18618238652, wanglirumail@126.com
About this study
Official title: 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.
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.
- Conditions
- AL Amyloidosis
- Being tested
- Teclistamab (Tec)
- Keywords
- teclistamab, complete hematological response
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Teclistamab monotherapy Receives: Drug: Teclistamab (Tec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete hematological response
Complete hematological response using ISA criteria
Measured: 3 months, 6 months
Secondary outcomes (8)
Minimal residual disease
Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10^-5.
Measured: 3 months, 6 months
Stringent dFLC response
dFLC ≤ 10 mg/L
Measured: 3 months, 6 months
TRAE
Treatment realted adverse events
Measured: 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.
Measured: 12 months, 24 months
OS
Overall survival
Measured: 12 months, 24 months
Renal Response
Renal Response according to ISA criteria
Measured: 3 months, 6 months, 12 months
Cardiac Response
Cardiac Response according to ISA criteria
Measured: 3 months, 6 months, 12 months
Hepatic Response
Hepatic Response according to ISA criteria
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start29 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University
- Investigators
- Jin Lu, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699394
- Sponsor's protocol ID
- 2023PHB319-001-03
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No