NCT06699394 Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
| NCT ID | NCT06699394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | AL Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-29 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-03-29 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.
Eligibility 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.
Contact & Investigator
Jin Lu, M.D.
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06699394 clinical trial?
This trial is open to participants of all sexes, studying AL Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06699394 currently recruiting?
Yes, NCT06699394 is actively recruiting participants. Contact the research team at pkuphliuyang@bjmu.edu.cn for enrollment information.
Where is the NCT06699394 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06699394 clinical trial?
NCT06699394 is sponsored by Peking University People's Hospital. The principal investigator is Jin Lu, M.D. at Peking University People's Hospital. The trial plans to enroll 20 participants.