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Clinical Trial Summary

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).


Clinical Trial Description

Building on the prior NXC-201 results in AL amyloidosis published by Kfir-Erenfeld et. al (2022) and Asherie et. al. (2023), this study will enroll additional patients with relapsed or refractory AL amyloidosis and assess the safety and efficacy of NXC-201. Subjects with relapsed/refractory AL amyloidosis will undergo leukapheresis at least one month prior to lymphodepletion, to provide starting material for NXC-201 CART manufacture. Subjects will be treated according to the following process for lymphodepletion: Days -5, -4 and -3 Cyclophosphamide 250mg/m2, IV infusion over 30 mins, followed immediately by Fludarabine 25 mg/m2 IV infusion over 30 minutes. NXC-201 CART is administered on Day 0, after lymphodepletion. Enrolled subjects will receive a dose of NXC-201 CAR-positive (CAR+) T cells. Dose escalation and expansion will be guided by safety review committee. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06097832
Study type Interventional
Source Nexcella Inc.
Contact Mehrdad Abedi, MD
Phone 916-734-5959
Email mabedi@UCDAVIS.EDU
Status Not yet recruiting
Phase Phase 1
Start date May 15, 2024
Completion date January 2039

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05996406 - Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14) Phase 2
Withdrawn NCT05692908 - An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis Phase 1
Withdrawn NCT04943302 - Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis Phase 2
Recruiting NCT05486481 - Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE) Phase 1/Phase 2
Recruiting NCT06376214 - Daratumumab for Patients With Light Chain Amyloidosis N/A
Recruiting NCT04973137 - A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis Phase 3
Completed NCT02015312 - A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL) Phase 2
Recruiting NCT04316442 - Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis Phase 1/Phase 2