Clinical trials: Systemic Light Chain Amyloidosis
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.
Amyloidosis
A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain…
- Trial name
- AT01-001 (NCT05235269)
- Testing
- 124I-AT-01
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Attralus, 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.
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
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.
Amyloidosis; Systemic
A Study of AT-02 in Subjects With Systemic Amyloidosis.
This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02. AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.
- Trial name
- NCT05951049
- Testing
- AT02
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Attralus, Inc.
Amyloidosis
A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis
The study will be conducted in two parts. The first (Part A) will be an open label single dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5 milligram (mg) [approximately equivalent to 0.1…
- Trial name
- NCT01777243
- Testing
- GSK2398852, GSK2315698
- Where
- 2 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
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.
Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
A Study to Investigate the Relationship Between Duration of Treatment and Response in Patients With Multiple Myeloma (MM) or Systemic AL Amyloidosis Treated in Real-life Practice
The study will provide information on outcomes in people with multiple myeloma, or systemic AL amyloidosis, or both, under standard care. AL is short for amyloid light-chain.
- Trial name
- DOrianT (NCT04659798)
- Where
- 14 sites in Spain
- Volunteers
- 240 people
- Sponsor
- Takeda
Amyloidosis; Systemic
Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis
This is a multicenter, international, three-part, Phase 1 study designed to evaluate the safety, tolerability, and PK of rising single doses of AT-02 in healthy volunteers and in subjects with systemic amyloidosis and to assess…
- Trial name
- AT02-001 (NCT05521022)
- Testing
- AT-02
- Where
- 11 sites in United States, Australia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Attralus, Inc.
Amyloidosis
A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis (NDSLCA)
The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis…
- Trial name
- NCT07388602
- Testing
- SCTC21C, Bortezomib, Dexamethasone
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Sinocelltech Ltd.
Amyloidosis, Systemic Light Chain Amyloidosis
A Safety Study of Carfilzomib in Patients With Previously-Treated Systemic Light Chain Amyloidosis
This is a dose finding study to evaluate the safety and determine the maximum tolerated dose of carfilzomib in patients with previously treated systemic light-chain amyloidosis.
- Trial name
- NCT01789242
- Testing
- Carfilzomib, Dexamethasone
- Where
- 10 sites in United States
- Volunteers
- 32 people
- Sponsor
- Criterium, Inc.
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
Relapsed or Refractory Systemic Light Chain Amyloidosis
Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB…
- Trial name
- NCT01659658
- Testing
- IXAZOMIB, Dexamethasone, Melphalan
- Where
- 66 sites in United States, Australia and 13 more
- Volunteers
- 177 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Amyloidosis
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL)…
- Trial name
- NCT03201965
- Testing
- Cyclophosphamide, Bortezomib, Dexamethasone, 40 mg
- Where
- 140 sites in United States, Australia and 20 more
- Volunteers
- 416 people
- Sponsor
- Janssen Research & Development, LLC
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.
Systemic Light Chain Amyloidosis
Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients
This study is a clinical trial aimed at the marketing of TQB2934 for injection. The project plans to enroll 70 subjects, including 13-21 subjects in Phase Ib, to evaluate the safety and preliminary efficacy, pharmacokinetic (PK)…
- Trial name
- NCT07266116
- Testing
- TQB2934 injection
- Where
- 27 sites in China
- Volunteers
- 70 people
- Sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Relapsed/Refractory Systemic Light Chain Amyloidosis
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.
- Trial name
- LINKER-AL2 (NCT06292780)
- Testing
- Linvoseltamab
- Where
- 21 sites in United States, Greece and 4 more
- Volunteers
- 220 people
- Sponsor
- Regeneron Pharmaceuticals
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
Phase 1 Study of GSK2315698 in Healthy Japanese Subjects
This is the first study in which GSK2315698 will be administered in Japanese population. The primary objective of the study is to investigate safety and tolerability, pharmacokinetics, and pharmacodynamics after single…
- Trial name
- NCT02953808
- Testing
- GSK2315698
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline