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 groupSponsors and collaborators
Nexcella Inc.
Lead sponsor
Immix Biopharma, Inc.
Collaborator
Source ClinicalTrials.gov