Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called NXC-201 (the study drug) for people with relapsed/refractory immunoglobulin light chain (AL) amyloidosis. The study drug is a CAR-T (chimeric antigen receptor) drug.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with AL amyloidosis
- Have disease that has come back (relapsed) or does not improve with treatment (refractory)
- Have received at least 1 previous line of therapy with a CD38 monoclonal antibody and a proteosome inhibitor
- Have symptomatic organ involvement (e.g., heart, kidney, liver/GI tract, peripheral nervous system)
- Have never received CAR T therapy for any reason
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will proceed through the following phases:
- Eligibility screening
- Leukapheresis (a procedure to remove white blood cells from your blood)
- CAR-T cell manufacturing (the study drug is made from your white blood cells that are removed during leukapheresis)
- Lymphodepletion (a chemotherapy regimen done 5 days before you receive the study drug that reduces the number of T cells in your blood)
- Study drug dosing (you will receive the study drug as an infusion and remain in the hospital for 10 days afterward)
- Follow-up (you will return to the clinic for several visits for physical exams and lab work)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Phase 1b Dose Expansion Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis
Principal Investigator
Cristiana Costa
Chase
Protocol Number
PRO00117561
NCT ID
NCT06097832
Phase
I
Enrollment Status
Pending Open to Enrollment