NCT06935162 Teclistamab in Previously Treated AL Amyloidosis
| NCT ID | NCT06935162 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | AL Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2026-12-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-05-21 with a primary completion date of 2026-12-31.
⚠ 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 is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06935162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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.
What phase is the NCT06935162 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06935162 currently recruiting?
Yes, NCT06935162 is actively recruiting participants. Contact the research team at shenkaini3@sina.com for enrollment information.
Where is the NCT06935162 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06935162 clinical trial?
NCT06935162 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 30 participants.