A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

NCT ID: NCT06649695

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2028-09-30

Brief Summary

This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab

Conditions

AL Amyloidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

Group Type: EXPERIMENTAL

Teclistamab

Intervention Type: DRUG

Teclistamab will be administered via a subcutaneous injection (SC)

Interventions

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

Intervention Type: DRUG

Other Intervention Names

JNJ-64007957

Eligibility Criteria

Inclusion Criteria

• Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry/ immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.
• Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry/ immunofluorescence/ immunoelectron microscopy/ mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2
• Mayo stage I-IIIA cardiac disease at Screening
• Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.
• Measurable hematologic disease: a dFLC >20 mg/L with an abnormal κ/λ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g/dL.
• Adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:
• Absolute neutrophils ≥1,000/mm3,
• Platelets ≥75,000/mm3,
• Hemoglobin ≥8.5 g/dL.
• Adequate organ function, defined as:
• Serum creatinine clearance (CKD-EPI formula) ≥20 mL/min,
• Serum SGPT/ALT <5.0 x Upper Limit of Normal (ULN),
• Serum total bilirubin <2.0 mg/dL or direct bilirubin ≤30% of the total, unless the patient has Gilbert's syndrome, where direct bilirubin should then be <2.0 mg/dL,
• Serum albumin ≥<2.5 gr/dl (medication to correct serum albumin levels is permitted).

Exclusion Criteria

• Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.
• Isolated soft-tissue involvement.
• Presence of non-AL amyloidosis.
• Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).
• Intolerance to dexamethasone that would prohibit treatment with trial therapy.
• MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering Myeloma, not requiring treatment.

Note: A MM diagnosis with a serum FLC ratio >100, as the only myeloma-defining event, does NOT constitute an exclusion.

• All hematologic malignancies, with the exception of low-risk Philadelphia chromosome negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic syndromes (MDS), not requiring treatment.
• Mayo stage IIIB cardiac disease at Screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development

UNKNOWN

Sponsor Role: collaborator

European Myeloma Network B.V.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Murielle Roussel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Limoges

Locations

South Australia Health

Adelaide, , Australia

Site Status: NOT_YET_RECRUITING

Westmead Hospital

Sydney, , Australia

Site Status: RECRUITING

CHU Limoges

Limoges, , France

Site Status: NOT_YET_RECRUITING

Paris St Louis

Paris, , France

Site Status: NOT_YET_RECRUITING

University Hospital Essen

Essen, , Germany

Site Status: RECRUITING

University Hospital Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

University Hospital Würzburg

Würzburg, , Germany

Site Status: NOT_YET_RECRUITING

General Hospital of Athens "Alexandra"

Athens, , Greece

Site Status: RECRUITING

Fondazione I.R.C.C.S Policlinico "San Matteo"

Pavia, , Italy

Site Status: NOT_YET_RECRUITING

UMC Utrecht

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Australia; France; Germany; Greece; Italy; Netherlands

Central Contacts

Sarah Lonergan

Role: CONTACT

sarah.lonergan@emn.org

+31 102687065

Emelie Asselbergs

Role: CONTACT

emelie.asselbergs@emn.org

+31 102687065

Facility Contacts

Horvath

Role: primary

Kwok

Role: primary

Roussel

Role: primary

Arnulf

Role: primary

Carpinteiro

Role: primary

Schönland

Role: primary

Kortüm

Role: primary

Kastritis

Role: primary

Palladini

Role: primary

Minnema

Role: primary

Other Identifiers

EMN40/64007957AMY2002

Identifier Type: -

Identifier Source: org_study_id