Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
ConditionLight Chain (AL) Amyloidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNexcella Inc.
About this trial
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).
Eligibility criteria
Qualifiers
≥18 years of age.
Voluntarily signed informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
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.
Disqualifiers
Prior treatment with CAR T therapy directed at any target.
Any therapy that is targeted to BCMA.
Stroke or seizure within 6 months of signing ICF.
Bone marrow plasma cells >30% and clinically symptomatic multiple myeloma with end organ damage (i.e. lytic bone lesions).
Trial design
Treatments tested in this trial
- NXC-201 CAR-T
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
18California
Sutter Health Alta Bates94704, Berkeley United States
City of Hope91010, Duarte United States
University of California Los Angeles90095, Los Angeles United States
University of California Davis Medical Center95817, Sacramento United States
Sponsors and collaborators
Nexcella Inc.
Lead sponsor
Immix Biopharma, Inc.
Collaborator
Source ClinicalTrials.gov