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

NCT06649695 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EMN40/64007957AMY2002
• Study Type: interventional
• Target: 30
• Locations: 6 countries
• Sites: 10

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

Keywords

teclistamab

Outcome Measures

Primary Outcomes (1)

• Hematologic Complete Response (CR) rate

  Percentage of participants achieving CR or better according to EHA/ISA guidelines

  baseline up to 3 cycles of treatment (approximately 3 months)

Secondary Outcomes (1)

• Hematologic Overall Response Rate (ORR) rate

  Baseline up to progression of disease or death (approximately 3,5 years)

Study Arms (1)

Teclistamab

EXPERIMENTAL

Teclistamab will be administered via a subcutaneous injection (SC)

Drug: Teclistamab

Interventions

Teclistamab DRUG

Teclistamab will be administered via a subcutaneous injection (SC)

Also known as: JNJ-64007957

Teclistamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• European Myeloma Network B.V.: lead
• Janssen Research & Development: collaborator

Study Sites (10)

South Australia Health

Adelaide, Australia

RECRUITING

Westmead Hospital

Sydney, Australia

RECRUITING

CHU Limoges

Limoges, France

RECRUITING

Paris St Louis

Paris, France

NOT YET RECRUITING

University Hospital Essen

Essen, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

RECRUITING

University Hospital Würzburg

Würzburg, Germany

RECRUITING

General Hospital of Athens "Alexandra"

Athens, Greece

RECRUITING

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

Pavia, Italy

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Study Officials

• Murielle Roussel, MD

  CHU Limoges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Del Pietro

CONTACT

+31 102687065; chiara.delpietro@emn.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: July 2, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-03

Locations

DE (3); AU (2); GR (1); FR (2); NL (1); IT (1)