Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloid... | NCT07079423

Studies
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis

NCT07079423

Sponsor

Peking Union Medical College Hospital

Status

Recruiting

Last Update Posted

Jul 23, 2025Actual

Enrollment

35Estimated

Phase

Phase 2

Conditions

AL Amyloidosis

Interventions

Teclistamab (Tec)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2025Actual

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 11, 2025

First Submission Date that Met QC Criteria

Jul 22, 2025

First Posted Date

Jul 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2025

Last Update Posted Date

Jul 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teclistamab	Experimental	Teclistamab will be administered via a subcutaneous injection	Drug: Teclistamab (Tec)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teclistamab (Tec)	Drug	Teclistamab will be administered via a subcutaneous injection	Teclistamab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	at 1 months after treatment initiation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy confirmed AL amyloidosis
Mayo 2004 stage IIIB
dFLC ≥ 50mg/L

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kaini Shen	Contact	86-13693339884		shenkaini3@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing		100730	China

Condition Browse Module

MeSH Terms

ID	Term
D000075363	Immunoglobulin Light-chain Amyloidosis

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D000686	Amyloidosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D051416	Focal Adhesion Protein-Tyrosine Kinases

Ancestor Terms

ID	Term
D011505	Protein-Tyrosine Kinases
D011494	Protein Kinases
D017853	Phosphotransferases (Alcohol Group Acceptor)
D010770	Phosphotransferases

Browse Leaves

Not provided

Browse Branches

Not provided