FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis (NCT05978661) | Clinical Trial Compass
RecruitingPhase 1
FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
China12 participantsStarted 2023-08-29
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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;
✓. dFLC \> 50mg/L;
✓. Expected survival ≥ 12 weeks;
✓. ECOG score ≤ 2 points;
✓. Female subjects with fertility should agree to practice an effective method of contraception from the day of signing the ICF until 365 days after the infusion. An effective method of contraception is defined as abstinence or contraceptive methods with an annual failure rate of \<1% specified in the plan.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
The proportion of subjects with dose-limiting toxicity
Timeframe: Within 28 days after FKC288 injection infusion
2
The proportion of subjects with adverse events
Timeframe: Within 24 weeks after FKC288 injection infusion
. 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.
✕. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have abnormal peripheral blood HBV DNA test results (HBV DNA test abnormality is defined as HBV DNA quantitative detection is higher than the detection center's detection lower limit or higher than the detection center's normal reference range or HBV DNA qualitative detection is positive); hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; the cytomegalovirus (CMV) DNA positive; syphilis testing RPR positive.
✕. Presence of uncontrollable active infections (excluding \<CTCAE grade 2 urinary and respiratory tract infections).
✕. Severe cardiovascular diseases, including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III), and severe arrhythmias.
✕. Subjects with hypertension that cannot be controlled by medication.