CAEL-101

DRUG5 trials

Conditions

AL AmyloidosisStage IIIb cardiac AL amyloidosisstage IIIa cardiac AL amyloidosis

Phase 2

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

CompletedNCT04304144

Alexion Pharmaceuticals, Inc.AL Amyloidosis

Start: 2020-03-18End: 2023-11-14Updated: 2025-03-05

Phase 3

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)

Active, not recruitingNCT04504825

Alexion Pharmaceuticals, Inc.AL Amyloidosis

Start: 2020-08-25End: 2027-10-22Updated: 2026-07-02

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)

Active, not recruitingNCT04512235

Alexion Pharmaceuticals, Inc.AL Amyloidosis

Start: 2020-11-03End: 2027-04-08Updated: 2026-06-17

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis

Active, not recruitingCTIS2022-503073-11-00

Alexion Pharmaceuticals Inc.Stage IIIb cardiac AL amyloidosis

Start: 2021-02-13Target: 56Updated: 2025-11-19

Active, not recruitingCTIS2022-503072-84-00

Alexion Pharmaceuticals Inc.stage IIIa cardiac AL amyloidosis

Start: 2021-02-13Target: 83Updated: 2025-12-17

Journal of Clinical Oncology2026-05-28

Development of a high-affinity antibody specific to the predominant λ light chain amyloid subtype for AL amyloidosis immunotherapy

Blood2025-11-03

Gene Expression Sets and Renal Profiling from the Renal AL Amyloid Involvement and NEOD00 (RAIN) Trial.

2024-07-11

Safety and Tolerability of Cael-101, an Anti-Amyloid Monoclonal Antibody, Combined with Anti-Plasma Cell Dyscrasia Therapy in Patients with Light-Chain Amyloidosis: 24-Month Results of a Phase 2 Study

Blood2023-11-024 citations

PB2150: CARDIAC AMYLOID REACHING FOR EXTENDED SURVIVAL (CARES) TRIALS: 2 PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, PHASE 3 TRIALS ASSESSING CAEL-101 IN PATIENTS WITH MAYO STAGES IIIA/IIIB AL AMYLOIDOSIS

HemaSphere2023-08-013 citations

S204: SAFETY AND TOLERABILITY OF CAEL-101, AN ANTI-AMYLOID MONOCLONAL ANTIBODY, COMBINED WITH ANTI-PLASMA CELL DYSCRASIA THERAPY IN PATIENTS WITH LIGHT-CHAIN AMYLOIDOSIS: 18-MONTH RESULTS OF A PHASE 2 STUDY

HemaSphere2023-08-012 citations

Enrolling patients in Cardiac Amyloid Reaching for Extended Survival (CARES) trials: Two placebo-controlled, double-blind, randomized, international phase 3 trials assessing CAEL-101 in patients with Mayo stage IIIa or stage IIIb AL amyloidosis.

Journal of Clinical Oncology2023-06-014 citations

1-Year Results from a Phase 2 Study to Determine Safety and Tolerability of Treating Patients with Light-Chain (AL) Amyloidosis with Cael-101, an Anti-Amyloid Monoclonal Antibody, Combined with Anti-Plasma Cell Dyscrasia

Blood2022-11-157 citations

Cardiac Amyloid Reaching for Extended Survival (CARES): Study Design of Two Placebo-Controlled, Double-Blind, Randomized, International Phase 3 Trials Assessing Cael-101 in Patients with Mayo Stage Iiia or Stage IIIb AL Amyloidosis

Blood2021-11-058 citations

Safety and Tolerability of Cael-101 in Combination with Anti-Plasma Cell Dyscrasia Therapy in Patients with AL Amyloidosis: 1-Year Results from an Open-Label Phase 2 Trial

Blood2021-11-052 citations

Updated Organ Response Results of an Open-Label Study to Evaluate the Safety and Tolerability of Cael-101 in Patients with AL Amyloidosis Receiving Anti-Plasma Cell Therapy

Blood2021-11-052 citations

Beyond Andromeda: Improving Therapy for Light Chain Amyloidosis.

2021-02-034 citations

Safety, Tolerability and Efficacy of Cael-101 in AL Amyloidosis Patients Treated on a Phase 2, Open-Label, Dose Selection Study to Evaluate the Safety and Tolerability of Cael-101 in Patients with AL Amyloidosis

Blood2020-11-059 citations

CAEL-101

Sponsors

Conditions

Phase 2

Phase 3

Related Papers