Clinical trials: Immunoglobulin Light-chain Amyloidosis
Light-Chain Amyloidosis
Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis
This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated…
- Trial name
- NCT01318902
- Testing
- Ixazomib, Dexamethasone
- Where
- 10 sites in United States, Canada and 3 more
- Volunteers
- 27 people
- Sponsor
- Millennium Pharmaceuticals, 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.
Newly Diagnosed Amyloidosis, Amyloidosis Stage I-IIIA
Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis
This study is researching a Regeneron drug called linvoseltamab ("study drug") alone compared to standard of care (SoC) combination to see if it can help treat participants who are newly diagnosed and previously untreated for…
- Trial name
- LINKER-AL1 (NCT07901725)
- Testing
- Linvoseltamab, Daratumumab, Bortezomib
- Volunteers
- 382 people
- Sponsor
- Regeneron Pharmaceuticals
AL Amyloidosis
Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability.
- Trial name
- OLE (NCT02613182)
- Testing
- NEOD001
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Prothena Biosciences Ltd.
Amyloidosis
A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis
GSK3039294 has been developed in order to offer an orally available alternative to parenteral CPHPC (GSK2315698 [metabolite of GSK3039294]) for plasma serum amyloid P component (SAP) depletion prior to use of anti SAP monoclonal…
- Trial name
- NCT02603172
- Testing
- GSK3039294
- Where
- United Kingdom
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
AL Amyloidosis
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who…
- Trial name
- PRONTO (NCT02632786)
- Testing
- NEOD001
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 129 people
- Sponsor
- Prothena Biosciences Ltd.
Acquired Factor X Deficiency
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of Coagadex in treating active bleeds and to manage peri-operative bleeding in participants with acquired factor X deficiency associated with AL amyloidosis.
- Trial name
- NCT06963216
- Testing
- Coagadex(R)
- Sponsor
- Kedrion S.p.A.
Amyloidosis
SAP Depleter Dose Assessment Study in Patients
This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the…
- Trial name
- NCT01406314
- Testing
- GSK2315698
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- GlaxoSmithKline
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
Amyloidosis; Systemic
A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis
This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.
- Trial name
- AT03-001 (NCT05201911)
- Testing
- 124I-AT03
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Attralus, 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.
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
Primary Amyloidosis
Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at…
- Trial name
- NCT01707264
- Testing
- NEOD001
- Where
- 7 sites in United States
- Volunteers
- 69 people
- Sponsor
- Prothena Biosciences Ltd.
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
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.
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
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.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Amyloidosis
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
- Trial name
- ALANIS (NCT07224672)
- Testing
- Belantamab mafodotin, Cyclophosphamide, Bortezomib
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline