FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
ConditionLight Chain Amyloidosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanjing University School of Medicine
About this trial
This study is a single-center exploratory clinical trial. It is estimated that 6-12 subjects will be enrolled. The "BOIN" dose escalation design is adopted. The main purpose is to evaluate the safety of FKC288 in the treatment of subjects with relapsed or refractory AL amyloidosis and explore the recommended phase II dose of FKC288 in the treatment of patients with relapsed/refractory systemic Light Chain (AL) amyloidosis.
Eligibility criteria
Qualifiers
The subject must personally sign a written informed consent form approved by the ethics committee before the start of the study;
The subject's age is ≥18 years old and <70 years old;
The subject must be diagnosed with light chain amyloidosis by pathological examination, with at least one major organ involved (heart, kidney, or liver);
The subject with recurrent/refractory light chain amyloidosis that achieved no response with conventional treatment;
Disqualifiers
Subjects who have received any of the following treatments prior to enrollment: 1) Subjects who have received gene therapy before enrollment; 2) Subjects who have received live vaccines within 4 weeks prior to enrollment; 3) Subjects has received other interventional clinical research drugs within 12 weeks before apheresis.
Subjects with central metastasis or complete intestinal obstruction.
Subject with moderate or more severe hydrothorax and ascites which are hard to control by conventional treatment and require continuous catheter drainage.
With an active malignant tumor in the past 5 years, unless it is a curable tumor and has been obviously cured.
Trial design
Treatments tested in this trial
- FKC288
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov