Actively Recruiting
FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Led by Nanjing University School of Medicine · Updated on 2023-11-15
12
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and under 70 years
- Diagnosed with light chain amyloidosis by pathology with at least one major organ involved (heart, kidney, or liver)
- Relapsed or refractory light chain amyloidosis with no response to conventional treatment
- Difference in free light chains (dFLC) greater than 50 mg/L
- Expected survival of at least 12 weeks
- ECOG performance status score of 2 or less
- Female participants of childbearing potential agree to effective contraception from consent until 365 days after infusion
- Adequate organ function including specific blood counts, liver and kidney function, heart function (left ventricular ejection fraction ≥ 50%), and stable coagulation
- Basic blood oxygen saturation above 95% in room air
- Signed informed consent before study start
You will not qualify if you...
- Prior gene therapy or live vaccines within 4 weeks
- Participation in other interventional clinical studies within 12 weeks before apheresis
- Central nervous system metastasis or complete intestinal obstruction
- Moderate or severe fluid buildup in chest or abdomen hard to control and requiring drainage
- Active malignant tumors in the past 5 years unless cured
- Positive for hepatitis B, C, HIV, CMV DNA, or syphilis with abnormal test results
- Uncontrolled active infections (except mild urinary or respiratory tract infections)
- Severe cardiovascular diseases including unstable angina, recent heart attack within 6 months, severe congestive heart failure (NYHA III or above), and severe arrhythmias
- Uncontrolled hypertension
- Unresolved or significant toxicities from previous treatments
- Major surgery within 2 weeks before enrollment or planned surgery during the study period (except local anesthesia)
- Solid organ transplant recipients
- Pregnant or breastfeeding women
- History of central nervous system diseases or consciousness disorders
- Other unstable systemic diseases requiring medication
- Known life-threatening allergic or hypersensitivity reactions to FKC288 or its components
- Significant bleeding or clotting disorders or receiving related therapies
- Other conditions judged inappropriate by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jinling Hospital
Nanjing, Jiangsu, China, 210016
Actively Recruiting
Research Team
X
Xianghua Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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