Light Chain (AL) Amyloidosis Clinical Trial
Official title:
Phase 1b Dose Expansion Study of NXC-201 for the Treatment of Patients With Relapsed or Refractory AL Amyloidosis
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).
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. ;
| 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| Withdrawn |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| Withdrawn |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 |