A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexion Pharmaceuticals, Inc.

About this trial

Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.

Eligibility criteria

Qualifiers

Confirmed histopathological diagnosis of AL amyloidosis

One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines

Measurable hematologic disease: dFLC > 20 mg/L or serum M-protein > 5g/L

Relapsed or refractory disease with a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.

Disqualifiers

Have any other form of amyloidosis other than AL amyloidosis

Mayo Stage IIIb AL amyloidosis

Oxygen saturation < 95% on room air

Systolic blood pressure <100mmHg

Trial design

Treatments tested in this trial

  • AZD0120

Treatment groups

91 Participants
are divided into 1 treatment group

Sponsors and collaborators