Clinical trials: Primary 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.
Relapsed/Refractory Multiple Myeloma, Amyloid Light-chain Amyloidosis
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA).
- Trial name
- NCT05839626
- Testing
- SAR445514
- Where
- 16 sites in Australia, Belgium and 5 more
- Volunteers
- 32 people
- Sponsor
- Sanofi
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.
Normal Pressure Hydrocephalus
Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples…
- Trial name
- NCT01092546
- Testing
- [18F]Flutemetamol
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- GE Healthcare
Healthy Volunteers
A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)
The purpose of this healthy volunteers drug-drug interaction study is to assess the CYP1A2 and CYP3A4 perpetrator interaction potential and CYP1A2 victim potential of TEV-56286 (anle138b).
- Trial name
- NCT05532358
- Testing
- anle138b (TEV-56286), Fluvoxamine 100 mg QD for 5 days
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- MODAG GmbH
Normal Pressure Hydrocephalus
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
This study will determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained…
- Trial name
- NCT01053312
- Testing
- [18F] Flutemetamol
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- GE Healthcare
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
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.
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.
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
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.
Relapsed or Refractory Multiple Myeloma
Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma
The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.
- Trial name
- NCT05503550
- Testing
- Talquetamab
- Sponsor
- Janssen Research & Development, LLC
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
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.
Progressive Supranuclear Palsy, Corticobasal Degeneration
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of NIO752 in Primary Tauopathies
This is a phase II study intended to evaluate the safety, tolerability and pharmacodynamics of NIO752 in participants with primary tauopathies.
- Conditions
- Progressive Supranuclear Palsy, Corticobasal Degeneration, Frontotemporal Lobar Degeneration, Tauopathies
- Trial name
- NCT07868328
- Testing
- NIO752
- Volunteers
- 48 people
- Sponsor
- Novartis Pharmaceuticals
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.
Tuberous Sclerosis, Angiofibroma
Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis Complex
The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients with tuberous sclerosis complex in the open-label…
- Conditions
- Tuberous Sclerosis, Angiofibroma, Hypomelanotic Macule, Plaque
- Trial name
- NCT02634931
- Testing
- NPC-12G gel
- Where
- Japan
- Volunteers
- 94 people
- Sponsor
- Nobelpharma
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
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.