AL AmyloidosisPhase 2NCT07079423
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
A Phase 2 study testing Teclistamab (Tec) in people with AL Amyloidosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 35 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- dFLC ≥ 50mg/L
Who cannot join
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
- Seropositive for human immunodeficiency virus
Show all 10Show fewer
- Hepatitis B virus (HBV)-DNA > 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L.
- Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) > 5 × upper limit of normal (ULN), total bilirubin > 2 × ULN, estimated glomerular filtration rate < 20 mL/min, or receiving renal replacement therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Kaini Shen, 86+13693339884, shenkaini3@sina.com
About this study
Official title: Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
- Conditions
- AL Amyloidosis
- Being tested
- Teclistamab (Tec)
- 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 will be administered via a subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Teclistamab | Experimental | Teclistamab will be administered via a subcutaneous injection Receives: Drug: Teclistamab (Tec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation
Stringent dFLC response is defined as dFLC < 10 mg/L or involved free light chain (FLC) ≤ 20 mg/L, and FLC will be tested using FreeLite assay (Binding Site).
Measured: at 1 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start28 Jun 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2027 (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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaini Shen, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079423
- Sponsor's protocol ID
- TEC-IIIB AL
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study
- ClinicalTrials.gov ID
- NCT07079423
- Acronym / sponsor ID
- TEC-IIIB AL
- Conditions
- AL Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 28 Jun 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teclistamab | Experimental | Drug: Teclistamab (Tec)Teclistamab will be administered via a subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- dFLC ≥ 50mg/L
Key exclusion criteria (10 listed)
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teclistamab (Tec)Teclistamab will be administered via a subcutaneous injection | Drug | Teclistamab |
Primary outcome
Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation
Time frame: at 1 months after treatment initiation
Stringent dFLC response is defined as dFLC < 10 mg/L or involved free light chain (FLC) ≤ 20 mg/L, and FLC will be tested using FreeLite assay (Binding Site).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Related trials for AL Amyloidosis
RecruitingPhase 1
Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
Relapsed/Refractory AL Amyloidosis
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Active, not recruitingPhase 2
Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
Multiple Myeloma, AL Amyloidosis
RecruitingPhase 2
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Multiple Myeloma, Refractory to Standard Treatment, Multiple Myeloma, Relapsed
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab (Tec) in people with AL Amyloidosis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaini Shen (86-13693339884, shenkaini3@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation (time frame: at 1 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.