Study Details

Open

Study of NXC-201 CAR-T in Patients with Light Chain (AL) Amyloidosis

The purpose of this research is to test the safety of NXC-201 (a CAR-T cell targeting the BCMA protein) at different doses in participants with relapsed/refractory AL amyloidosis, and to confirm the best dose for further testing. In addition, the study will evaluate the effectiveness of NXC-201 in treating relapsed/refractory AL amyloidosis

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

You will meet with the study team to determine if you are eligible for the study. You will have an exam and some tests done to see if you can take part in the study. If you are eligible, you will have blood drawn to start the manufacturing of the investigational treatment, NXC-201. When your treatment (cellular therapy product) is ready, you will be given 3 days of chemotherapy to improve the likelihood that your cellular therapy product will thrive once infused. After the chemotherapy, you will receive the NXC-201 infusion. You will need to stay in the hospital for a short stay after you receive your treatment. After treatment, you will return to clinic to meet with the study for exams, testing, and questionnaires.

Incentives

Potential to be reimbursed for hotel stays

In-person visits:
30

Total length of participation:
7 weeks of screening and treatment, 2 years of active follow up, up to 15 years for long term follow up

Looking for Specific Volunteers

Able to participate:

You have a diagnosis of AL amyloidosis
You have been treated with at least one line of therapy
You have organ involvement (heart, kidney, liver/GI tract, or peripheral nervous system) that is causing symptoms
If you've had side effects to prior treatments for AL amyloidosis, those side effects must be considered mild to moderate at time of enrollment
You are able to swallow pills

Not eligible if:

You have had prior treatment with any CAR T therapy or therapy targeted to BCMA
You have clinically symptomatic multiple myeloma with end organ damage or bone marrow plasma cells >30%
Significant heart disease, stroke or seizure within 6 months, or have had unstable angina or myocardial infarction requiring intervention within last 3 months
You have ongoing evidence of significant arrhythmias or insufficient blood pressure (while laying down) despite treatment
You have known HIV, Hepatitis B, or Hepatitis C with detectable viral load

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Samuel Rubinstein
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Other Cancers)

IRB Number

25-0436

ClinicalTrials.gov

NCT06097832