Teclistamab in Previously Treated AL Amyloidosis
ConditionAL Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous anti-BCMA targeted therapy
Co-morbidity of uncontrolled infection
Co-morbidity of other active malignancy
Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
Trial design
Design model
Single group
Treatments tested in this trial
Teclistamab (Tec)
DrugTeclistamab will be administered via a subcutaneous injection
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TeclistamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hematologic complete response (CR) at 3 months after treatment initiation
Time frame
at 3 months after treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov