Clinical trials: Light Chain (AL) Amyloidosis
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.
AL Amyloidosis
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab
- Trial name
- NCT06649695
- Testing
- Teclistamab
- Where
- 9 sites in Australia, France and 4 more
- Volunteers
- 30 people
- Sponsor
- European Myeloma Network B.V.
Myeloma Multiple, Plasma Cell Leukemia
The Norwegian Immunotherapy in Multiple Myeloma Study
The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway.
- Conditions
- Myeloma Multiple, Plasma Cell Leukemia, AL Amyloidosis
- Trial name
- NIMMS (NCT06855121)
- Testing
- Teclistamab, Elranatamab, Ciltacabtagene Autoleucel
- Where
- 23 sites in Norway
- Volunteers
- 400 people
- Sponsor
- St. Olavs Hospital
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.
AL Amyloidosis
Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis
This phase I trial studies the side effects of isatuximab and to see how well it works in treating patients with high risk immunoglobulin light chain amyloidosis (AL amyloidosis).
- Trial name
- NCT04754945
- Testing
- Bortezomib, Cyclophosphamide, Dexamethasone
- Where
- 6 sites in United States
- Volunteers
- 11 people
- Sponsor
- Emory University
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.
Systemic Amyloidosis, ATTR Amyloidosis
Hungarian National Systemic Amyloidosis Registry
This registry is an observational, multicenter, retrospective and prospective, non-pharmacological study designed to collect and analyze data from patients with systemic amyloidosis treated in inpatient and outpatient cardiology…
- Conditions
- Systemic Amyloidosis, ATTR Amyloidosis, AL Amyloidosis, Amyloid Cardiomyopathy
- Trial name
- AMYREG (NCT07689331)
- Where
- 12 sites in Hungary
- Volunteers
- 300 people
- Sponsor
- Semmelweis University
Amyloidosis; Systemic, AL Amyloidosis
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%.
- Trial name
- NCT06192979
- Testing
- Daratumumab, Bortezomib, Dexamethasone
- Where
- 7 sites in China
- Volunteers
- 41 people
- Sponsor
- Jin Lu, MD
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.
Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms
Evaluation of Skin Tests in Biotherapy Allergies
Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases.
- Conditions
- Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms, Small Cell Bronchial Carcinomas, Bronchial Carcinoma
- Trial name
- ETCABIO (NCT06971848)
- Testing
- Drug skin tests (investigating hypersensitivity to a biotherapy)
- Where
- France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospital, Angers
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.
Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Significance (MGUS)
Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging
The goal of this clinical trial is to evaluate whether ¹⁸F-florbetaben PET/MR can detect systemic amyloid deposits early and noninvasively in patients with monoclonal gammopathy.
- Conditions
- Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Significance (MGUS), Multiple Myeloma, AL Amyloidosis
- Trial name
- MGUS-PET (NCT07624760)
- Testing
- ¹⁸F-florbetaben
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- University of Zurich
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
Towards Effective, Patient-tailored Anti-plasma Cell Therapies in AL Amyloidosis: Predicting Drug Response and Overcoming Drug Resistance
Through an observational clinical study, partly prospective and partly retrospective, based on the collection of clinical data and on in vitro experimental analyses carried out on residual biological samples obtained during…
- Trial name
- NCT07585331
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
AL Amyloidosis
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD…
- Trial name
- NCT06022939
- Testing
- Autologous Hematopoietic Stem Cell Transplantation, Biopsy, Biospecimen Collection
- Where
- 117 sites in United States
- Volunteers
- 338 people
- Sponsor
- SWOG Cancer Research Network
AL Amyloidosis, POEMS Syndrome
One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS
By detailed sequence analysis and subsequent biophysical characterization of prototypic light chains, this project aims to identify sequence fingerprints in IGLV1-44 light chains leading to AL amyloidosis and POEMS syndrome.
- Conditions
- AL Amyloidosis, POEMS Syndrome, Multiple Myeloma
- Trial name
- ALPS (NCT07448935)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
AL Amyloidosis
BCMA/CD3 BiTE for RRAL or NDAL Amyloidosis With Insufficient Depth of Hematologic Response After Induction Therapy
The goal of this clinical trial is to evaluate the effectiveness and safety of CM-336, which is a BCMA/CD3 BiTE, in patients with relapsed/refractory AL amyloidosis or newly diagnosed AL amyloidosis with insufficient depth of…
- Trial name
- NCT06769555
- Testing
- CM-336 BCMA/CD3 bispecific antibody
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
AL Amyloidosis
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.
- Trial name
- NCT04392960
- Testing
- [18F]Florbetaben
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
AL Amyloidosis
A Registry of AL Amyloidosis (ReAL)
The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.
- Trial name
- ReAL (NCT04839003)
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia