A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Study ID
- NCT07081646
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Amyloidosis
- Light Chain Amyloidosis
- Refractory AL Amyloidosis
- Relapsed AL Amyloidosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AZD0120 — DRUGParticipants will receive AZD0120 via intravenous (IV) infusion.
Study Details
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.
Key Dates
- Start date
- Aug 18, 2025
- Status verified
- Mar 2026
- Primary completion
- Aug 15, 2029
- Completion
- Feb 14, 2031
Study Design
- Enrollment
- 91 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: AZD0120Participants will receive weight-based dose of AZD0120.
Primary Outcome Measure
Phase 1b: Number of Participants With incidence and severity of Treatment-emergent Adverse Events [ Time Frame: Through study completion, a minimum of 6 months ]
Central Contacts
- Alexion Pharmaceuticals, Inc. (Sponsor)1-855-752-2356
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85028 | - |
| Research Site | San Francisco | California | 94143 | - |
| Research Site | Tampa | Florida | 33612 | - |
| Research Site | Boston | Massachusetts | 02215 | - |
| Research Site | Detroit | Michigan | 48201 | - |
| Research Site | Rochester | Minnesota | 55905 | - |
| Research Site | St Louis | Missouri | 63110 | - |
| Research Site | New York | New York | 10016 | - |
| Research Site | New York | New York | 10032 | - |
| Research Site | New York | New York | 10065 | - |
| Research Site | Cleveland | Ohio | 44195 | - |
| Research Site | Nashville | Tennessee | 37232 | - |
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