Teclistamab treatment for patients with AL Amyloidosis
Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study
This study is testing if a new treatment called teclistamab can help people with AL Amyloidosis who haven't responded well to previous therapies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | daratumumab, teclistamab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06935162 on ClinicalTrials.gov |
What this trial studies
This phase II study evaluates the efficacy and safety of teclistamab in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis. Participants must have received at least one line of treatment and show signs of relapse or insufficient response to prior therapies. The study aims to determine how well teclistamab works in this specific patient population and to assess any associated safety concerns.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-confirmed AL Amyloidosis who have previously received treatment including daratumumab and bortezomib.
Not a fit: Patients with active malignancies, uncontrolled infections, or those who have previously received anti-BCMA targeted therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with AL Amyloidosis who have not responded adequately to previous treatments.
How similar studies have performed: While this approach is being explored in this specific context, similar studies with teclistamab have shown promise in treating other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy confirmed AL amyloidosis * Patients must have received at least one line of treatment, including daratumumab and bortezomib * Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment * dFLC \> 50mg/L Exclusion Criteria: * Previous anti-BCMA targeted therapy * Co-morbidity of uncontrolled infection * Co-morbidity of other active malignancy * Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia * Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker) * Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia * Seropositive for human immunodeficiency virus * Hepatitis B virus (HBV)-DNA \> 1000 copies/mL * Seropositive for hepatitis C (except in the setting of a sustained virologic response) * Neutrophil \<1×10E9/L, hemoglobin \< 8g/dL, or platelet \< 75×10E9/L. * Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 5 × upper limit of normal (ULN), total bilirubin \> 2 × ULN, eGFR \< 20 mL/min, or receiving renal replacement therapy
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Kaini Shen
- Email: shenkaini3@sina.com
- Phone: 86-13693339884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.