Clinical trials: AL Amyloidosis
Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at…
- Trial name
- NCT05652335
- Testing
- JNJ-79635322
- Where
- 29 sites in United States, Belgium and 5 more
- Volunteers
- 180 people
- Sponsor
- Janssen Research & Development, LLC
Amyloid Light Chain (AL) Amyloidosis
Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Amyloid light chain (AL) amyloidosis is a rare disease caused by abnormal plasma cells producing misfolded light chain proteins that deposit in organs, leading to organ dysfunction and failure.
- Trial name
- NCT07793422
- Testing
- Etentamig, Daratumumab, Cyclophosphamide
- Volunteers
- 370 people
- Sponsor
- AbbVie
Primary Light Chain (AL) Amyloidosis
A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Primary AL Amyloidosis
This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory primary light chain (AL) amyloidosis.The primary objectives are to assess the safety of FKC289 and to establish the…
- Trial name
- NCT07765524
- Testing
- FKC289 infusion
- Where
- 11 sites in China
- Volunteers
- 32 people
- Sponsor
- Shenzhen Fosun Kairos Biotechnology Co., Ltd.
Cardiac Amyloidosis, AL Amyloidosis
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac…
- Conditions
- Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
- Trial name
- CArdiag (NCT05184088)
- Testing
- [18F]florbetaben
- Where
- 14 sites in United States, Germany and 2 more
- Volunteers
- 244 people
- Sponsor
- Lantheus Germany GmbH
Relapsed/Refractory AL Amyloidosis
Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
This is a Phase 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.
- Trial name
- NCT07250269
- Testing
- GC012F Injection
- Where
- 9 sites in China
- Volunteers
- 9 people
- Sponsor
- Gracell Biotechnologies (Shanghai) Co., Ltd.
Light Chain (AL) Amyloidosis
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL)…
- Trial name
- NEXICART-3 (NCT07709715)
- Testing
- NXC-201, Dara-CyBorD
- Volunteers
- 260 people
- Sponsor
- Nexcella Inc.
Light Chain (AL) Amyloidosis
Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
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).
- Trial name
- NEXICART-2 (NCT06097832)
- Testing
- NXC-201 CAR-T
- Where
- 18 sites in United States
- Volunteers
- 45 people
- Sponsor
- Nexcella Inc.
AL Amyloidosis
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04504825
- Testing
- CAEL-101, cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
- Where
- 90 sites in United States, Australia and 17 more
- Volunteers
- 125 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Relapsed AL Amyloidosis, Refractory AL Amyloidosis
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
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.
- Conditions
- Relapsed AL Amyloidosis, Refractory AL Amyloidosis, Light Chain Amyloidosis, Amyloidosis
- Trial name
- ALACRITY (NCT07081646)
- Testing
- AZD0120
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 91 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
AL Amyloidosis
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04512235
- Testing
- CAEL-101, cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen
- Where
- 110 sites in United States, Australia and 17 more
- Volunteers
- 281 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Immunoglobulin Light Chain (AL) Amyloidosis
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma…
- Trial name
- NCT06158854
- Testing
- ABBV-383 (Etentamig)
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 76 people
- Sponsor
- AbbVie
Light Chain (AL) Amyloidosis
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
- Trial name
- AFFIRM-AL (NCT04973137)
- Testing
- Birtamimab, Standard of Care Chemotherapy
- Where
- 110 sites in United States, Australia and 21 more
- Volunteers
- 208 people
- Sponsor
- Prothena Biosciences Ltd.
AL Amyloidosis
Study of Eque-cel CAR-T Therapy in Newly Diagnosed Severe AL Amyloidosis
The goal of this clinical trial is to learn if Equecabtagene Autoleucel(Eque-cel), a Chimeric Antigen Receptor T-cell (CAR-T) therapy, works to treat severe Light Chain (AL) Amyloidosis in newly diagnosed adults with Mayo Stage…
- Trial name
- NCT07055724
- Testing
- Eque-cel CAR-T Therapy
- Volunteers
- 17 people
- Sponsor
- Nanjing IASO Biotechnology Co., Ltd.
AL Amyloidosis
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04304144
- Testing
- CAEL-101, SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD), Daratumumab
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
AL Amyloidosis
Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
The purpose of this study is to examine the tolerance, safety, pharmacokinetics, and possible clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive chimeric (Ch) IgG1 mAb 11-1F4 in patients with…
- Trial name
- NCT02245867
- Testing
- Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Amyloidosis, AL Amyloidosis
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
This is a single arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis.
- Trial name
- NCT05199337
- Testing
- ZN-d5
- Where
- 21 sites in United States, Australia and 5 more
- Volunteers
- 18 people
- Sponsor
- K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Primary Systemic (AL) Amyloidosis
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis.
- Trial name
- VITAL (NCT02312206)
- Testing
- NEOD001
- Where
- 79 sites in United States, Australia and 13 more
- Volunteers
- 260 people
- Sponsor
- Prothena Biosciences Ltd.
Light Chain (AL) Amyloidosis
An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis
This is a Phase 1 open-label, dose escalation trial designed to identify the recommended phase 2 dose of STI-6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with relapsed or refractory systemic…
- Trial name
- NCT05692908
- Testing
- STI-6129
- Sponsor
- Sorrento Therapeutics, Inc.
Light Chain (AL) Amyloidosis
Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis
The STI-6129-001 study is a three-stage, multicenter, open-label, dose-finding, phase 1b/2a trial. It is designed primarily to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy…
- Trial name
- NCT04316442
- Testing
- STI-6129
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sorrento Therapeutics, Inc.
AL Amyloidosis
A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis
This is a phase 1/2 open label study of melphalan flufenamide (melflufen) in combination with dexamethasone for participants with Al amyloidosis following at least one prior line of therapy.
- Trial name
- NCT04115956
- Testing
- Melphalan-Flufenamide (Melflufen), Dexamethasone
- Where
- 9 sites in United States, Czechia and 7 more
- Volunteers
- 6 people
- Sponsor
- Oncopeptides AB