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 (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT06649695 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCMA-targeted therapy disqualifies patients from enrollment.
Does this trial require TTR?
Yes, TTR mutation is a required biomarker for enrollment.
Does this trial require IGK?
Yes, IGK overexpression is a required biomarker for enrollment.
Does this trial require IGL?
Yes, IGL overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage MAYO STAGE I or MAYO STAGE II or MAYO STAGE IIIA is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages