Clinical trial · Interventional
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study
NCT06699394CI-TRIAL-00088866recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Teclistamab (Tec) | Drug | Teclistamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Group 1
- description
- Teclistamab monotherapy
- interventionNames
- Drug: Teclistamab (Tec)
Primary outcomes (1)
- measure
- Complete hematological response
- timeFrame
- 3 months, 6 months
- description
- Complete hematological response using ISA criteria
Secondary outcomes (8)
- measure
- Minimal residual disease
- timeFrame
- 3 months, 6 months
- description
- Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10\^-5.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.