Phase 1b/2 Study of NXC-201 for the Treatment of Patients With Relapsed or Refractory AL Amyloidosis
Nexcella Inc.
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).
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…
Eligibility
- Age range
- 18–120 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥18 years of age. 2. Voluntarily signed informed consent form (ICF). 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 4. Histologically proven systemic AL amyloidosis confirmed by positive Congo red staining with green birefringence on polarized light microscopy in an organ outside the bone marrow and evidence of a measurable clonal plasma cell disease that requires active treatment. 1. An underlying plasma cell disorder can be identified by one of the following: clonal plasma cells in the BM, monoclonal protein in the serum or urine, or abnormal…
Interventions
- BiologicalNXC-201 CAR-T
NXC-201 (formerly HBI0101) CAR-T is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The NXC-201 CAR-T is provided fresh without cryopreservation.
Locations (18)
- Sutter Health Alta BatesBerkeley, California
- City of HopeDuarte, California
- University of California Los AngelesLos Angeles, California
- University of California Davis Medical CenterSacramento, California
- Stanford UniversityStanford, California
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia