Clinical trials: Light-Chain Amyloidosis
Primary Light-Chain Amyloidosis
Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis
to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis
- Trial name
- NCT07039578
- Testing
- CM336 Injection(Low dose group), CM336 Injection(High dose group)
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- Keymed Biosciences Co.Ltd
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.
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.
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.
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.
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.
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
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.
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
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.
AL Amyloidosis, Amyloidosis
Quality of Life (QOL) Registry for Patients With AL Amyloidosis
This is an online registry to document the psychometric properties of SF-36v2 among patients with AL Amyloidosis, to document patients' burden of disease, to better understand the patient's experience and to follow quality of…
- Trial name
- NCT02574676
- Testing
- non-interventional
- Where
- United States
- Volunteers
- 343 people
- Sponsor
- Prothena Biosciences Ltd.
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.
AL Amyloidosis
Study in Subjects With Light Chain (AL) Amyloidosis
The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who have completed Study NEOD001-201.
- Trial name
- NCT03154047
- Testing
- NEOD001
- Where
- 34 sites in United States, Australia and 8 more
- Volunteers
- 80 people
- Sponsor
- Prothena Biosciences Ltd.
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.