Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT06097832
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2023-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
Sponsor:
Nexcella Inc.
Organization:
Study Overview
Official Title:
Phase 1b/2 Study of NXC-201 for the Treatment of Patients With Relapsed or Refractory AL Amyloidosis
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEXICART-2
Brief 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).
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: