NXC-201 CAR-T for Amyloidosis
(NEXICART-2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires a washout period of at least 4 weeks from any previous investigational treatment and no systemic therapy for AL amyloidosis within 14 days prior to leukapheresis. Additionally, therapeutic doses of steroids are not allowed within 2 weeks prior to leukapheresis.
What data supports the effectiveness of the treatment NXC-201 CAR-T for Amyloidosis?
Research shows that CAR T cell therapy, which is a type of treatment that uses modified immune cells to target cancer cells, has been effective in treating conditions like multiple myeloma and amyloidosis. In some cases, patients with amyloidosis who received CAR T therapy targeting specific proteins showed good responses and manageable side effects.12345
Is NXC-201 CAR-T therapy safe for humans?
What makes the NXC-201 CAR-T treatment unique for amyloidosis?
What is the purpose of this trial?
Open-label Phase 1b Dose Escalation/Dose Expansion study exploring the safety and efficacy of NXC-201 in patients with relapsed or refractory light chain amyloidosis (AL).
Research Team
Mehrdad Abedi, MD
Principal Investigator
University of California, Davis
Eligibility Criteria
This trial is for adults with relapsed or refractory light chain amyloidosis who have had previous treatments. They must not be pregnant, agree to birth control, and have measurable disease. People with inadequate organ function, recent other therapies, certain blood disorders, active infections or second malignancies are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis
Subjects undergo leukapheresis to provide starting material for NXC-201 CART manufacture
Lymphodepletion
Subjects receive Cyclophosphamide and Fludarabine infusions for lymphodepletion
Treatment
NXC-201 CART is administered to subjects after lymphodepletion
Dose Escalation and Expansion
Subjects receive escalating doses of NXC-201 CAR-positive T cells, guided by safety review committee
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- NXC-201
NXC-201 is already approved in United States, European Union for the following indications:
- None approved yet; under investigation for AL Amyloidosis and Multiple Myeloma
- None approved yet; under investigation for AL Amyloidosis and Multiple Myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nexcella Inc.
Lead Sponsor
Immix Biopharma, Inc.
Industry Sponsor