OncoMatch/Clinical Trials/NCT06649695
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
Is NCT06649695 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Teclistamab for al amyloidosis.
Treatment: Teclistamab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: TTR mutation (negative for transthyretin mutations associated with hereditary amyloidosis)
Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis
Required: IGK overexpression (clear evidence of κ light chains in amyloid deposits)
clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement
Required: IGL overexpression (clear evidence of λ light chains in amyloid deposits)
clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement
Disease stage
Required: Stage MAYO STAGE I, MAYO STAGE II, MAYO STAGE IIIA (Mayo)
Excluded: Stage MAYO STAGE IIIB
Mayo stage I-IIIA cardiac disease at Screening; Mayo stage IIIB cardiac disease at Screening [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: antibody-drug conjugate (daratumumab)
Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib
Must have received: proteasome inhibitor (bortezomib)
Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib
Cannot have received: BCMA-targeted therapy
Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics)
Lab requirements
Blood counts
Absolute neutrophils ≥1,000/mm3; Platelets ≥75,000/mm3; Hemoglobin ≥8.5 g/dL
Kidney function
Serum creatinine clearance (CKD-EPI formula) ≥20 mL/min
Liver function
Serum SGPT/ALT <5.0 x 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
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 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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