Study of NXC-201 CAR-T in Patients With Light Chain (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).
| Condition(s) | Light Chain (AL) Amyloidosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 free light chain ratio. 2. Because AL amyloidosis may present with low volumes of bone marrow plasma cells, prior biopsies demonstrating clonal plasma cell populations may be used to determine eligibility |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Lead sponsor | Nexcella Inc. |
| Locations | Berkeley, California, United States; Duarte, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Stanford, California, United States; Atlanta, Georgia, United States (+12 more sites) |
| Start date | 2024-06-05 |
| NCT ID | NCT06097832 |
| Official listing | https://clinicaltrials.gov/study/NCT06097832 |