Using teclistamab to treat systemic AL amyloidosis
Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study
This study is testing if teclistamab can help people with systemic AL amyloidosis who haven't responded to other treatments by seeing if it can eliminate harmful plasma cells and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | daratumumab, teclistamab |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06699394 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of teclistamab in treating systemic AL amyloidosis, focusing on achieving a complete hematological response. It is a single-arm, multi-center, prospective study where participants receive teclistamab as a treatment option after failing standard therapies like daratumumab and bortezomib. The goal is to determine if teclistamab can significantly improve patient outcomes by eliminating cloned plasma cells. The study will assess both the efficacy and safety of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with systemic AL amyloidosis who have not achieved a complete hematological response after standard treatments.
Not a fit: Patients with active multiple myeloma, severe infections, or other advanced malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved hematological responses and better clinical outcomes for patients with systemic AL amyloidosis.
How similar studies have performed: While teclistamab is a newer treatment, similar studies targeting hematological responses in amyloidosis have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of systemic AL amyloidosis; 2. Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response; 3. Life expectancy greater than 12 weeks; 4. HGB ≥70g/L; 5. Blood oxygen saturation \> 90%; 6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; 7. Informed consent explained to, understood by and signed by the patient. Exclusion Criteria: 1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma. 2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 3. Severe or persistent infection that cannot be effectively controlled; 4. Presence of severe autoimmune diseases or immunodeficiency disease; 5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); 6. Patients with HIV infection or syphilis infection; 7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking University Peoples Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Fuxing Hospital affiliated to Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Jin Lu, M.D. — Peking University People's Hospital
- Study coordinator: Yang Dr, M.D.
- Email: pkuphliuyang@bjmu.edu.cn
- Phone: +86-10-88326542
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.