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

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

Study Overview

• Status: Recruiting
• Conditions: AL Amyloidosis
• Intervention / Treatment: Drug: Teclistamab

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chiara Del Pietro; Phone Number: +31 102687065; Email: chiara.delpietro@emn.org

Study Locations

• Australia
  • Adelaide, Australia
    • Recruiting
    • South Australia Health
    • Contact: Horvath
  • Sydney, Australia
    • Recruiting
    • Westmead Hospital
    • Contact: Kwok
• France
  • Limoges, France
    • Recruiting
    • CHU Limoges
    • Contact: Roussel
  • Paris, France
    • Not yet recruiting
    • Paris St Louis
    • Contact: Arnulf
• Germany
  • Essen, Germany
    • Recruiting
    • University Hospital Essen
    • Contact: Carpinteiro
  • Heidelberg, Germany
    • Recruiting
    • University Hospital Heidelberg
    • Contact: Schönland
  • Würzburg, Germany
    • Recruiting
    • University Hospital Wurzburg
    • Contact: Kortüm
• Greece
  • Athens, Greece
    • Recruiting
    • General Hospital of Athens "Alexandra"
    • Contact: Kastritis
• Italy
  • Pavia, Italy
    • Recruiting
    • Fondazione I.R.C.C.S Policlinico "San Matteo"
    • Contact: Palladini
• Netherlands
  • Utrecht, Netherlands
    • Recruiting
    • UMC Utrecht
    • Contact: Minnema

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teclistamab; Teclistamab will be administered via a subcutaneous injection (SC)	Drug: Teclistamab; Teclistamab will be administered via a subcutaneous injection (SC); Other Names: JNJ-64007957

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematologic Overall Response Rate (ORR) rate	Percentage of participants achieving Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) or better according to EHA/ISA guidelines	Baseline up to progression of disease or death (approximately 3,5 years)

Collaborators and Investigators

• Sponsor: European Myeloma Network B.V.
• Collaborators: Janssen Research & Development
• Investigators: Principal Investigator: Murielle Roussel, MD, CHU Limoges

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: teclistamab
• Additional Relevant MeSH Terms: Neoplasms; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Paraproteinemias; Proteostasis Deficiencies; Amyloidosis; Nutritional and Metabolic Diseases; Immunoglobulin Light-chain Amyloidosis
• Other Study ID Numbers: EMN40/64007957AMY2002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes