Clinical trials: Anemia, Hemolytic, Autoimmune
Warm Autoimmune Hemolytic Anemia
To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia.
- Trial name
- ASCEND-WAIHA (NCT04253236)
- Testing
- RVT-1401 680 mg/weekly, RVT-1401 340 mg/weekly
- Where
- 21 sites in United States, Israel and 4 more
- Volunteers
- 5 people
- Sponsor
- Immunovant Sciences GmbH
Cold Agglutinin Disease
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number…
- Trial name
- NCT05132127
- Testing
- sutimlimab
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Sanofi
Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
Cold Agglutinin Disease Real World Evidence Registry
This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS).
- Trial name
- CADENCE (NCT05791708)
- Testing
- Sutimlimab
- Where
- 68 sites in United States, Austria and 6 more
- Volunteers
- 429 people
- Sponsor
- RECORDATI GROUP
Warm Autoimmune Hemolytic Anemia (wAIHA)
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
Primary Objectives: Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA Part B: To evaluate the efficacy of the selected dose in adults with wAIHA Secondary Objectives…
- Trial name
- NCT04661033
- Testing
- Isatuximab SAR650984
- Where
- 6 sites in United States, France and 4 more
- Volunteers
- 8 people
- Sponsor
- Sanofi
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
The primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy…
- Trial name
- NCT06004947
- Testing
- CCX168, Midazolam, Celecoxib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Autoimmune Hemolytic Anemia (AIHA)
HY001N for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.
The goal of this clinical trial is to learn if HY001N cell injection safety and tolerability in adult patients with autoimmune hemolytic anemia after failure of 3 or more lines of therapy.
- Trial name
- NCT07748533
- Testing
- HY001N Cell Injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Juventas Cell Therapy Ltd.
Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias (RUBY-4)
The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and…
- Conditions
- Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
- Trial name
- NCT05757570
- Testing
- Povetacicept
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 30 people
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
Cold Agglutinin Disease
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin…
- Trial name
- NCT05096403
- Testing
- Pegcetacoplan
- Where
- 44 sites in United States, Austria and 12 more
- Volunteers
- 24 people
- Sponsor
- Swedish Orphan Biovitrum
Warm Autoimmune Hemolytic Anemia
ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).
- Trial name
- NCT04256148
- Testing
- ALXN1830
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
Autoimmune Haemolytic Anaemia
A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin…
- Trial name
- NCT04269551
- Testing
- BIVV020
- Where
- 10 sites in United States, Germany and 4 more
- Volunteers
- 12 people
- Sponsor
- Bioverativ, a Sanofi company
Autoimmune Haemolytic Anaemia
A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female…
- Trial name
- LUMINA 3 (NCT07086976)
- Testing
- rilzabrutinib
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 90 people
- Sponsor
- Sanofi
Chronic Immune Thrombocytopenia, Autoimmune Hemolytic Anemia
Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).
- Trial name
- NCT07603557
- Testing
- BMS-986353, Fludarabine Phosphate, Cyclophosphamide
- Where
- 8 sites in United States, Denmark and 2 more
- Volunteers
- 52 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
Cold Agglutinin Disease
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants…
- Trial name
- Cadenza (NCT03347422)
- Testing
- sutimlimab (BIVV009)
- Where
- 53 sites in United States, Australia and 12 more
- Volunteers
- 42 people
- Sponsor
- Bioverativ, a Sanofi company
Alpha-Thalassemia, Beta-Thalassemia
FLOWER: Following Longitudinal Outcomes With Epidemiology for Rare Diseases
FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases.
- Conditions
- Alpha-Thalassemia, Beta-Thalassemia, Amyloidosis, Amyotrophic Lateral Sclerosis
- Trial name
- NCT06539169
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- xCures
B-cell Acute Lymphoblastic Leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL)
A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia
The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed/refractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia.
- Conditions
- B-cell Acute Lymphoblastic Leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL), Autoimmune Hemolytic Anemia (AIHA)
- Trial name
- NCT07205315
- Testing
- GT801 Injection
- Where
- 2 sites in China
- Volunteers
- 28 people
- Sponsor
- Grit Biotechnology
Autoimmune Cytopenia, Immune Thrombocytopenia (ITP)
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
- Conditions
- Autoimmune Cytopenia, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia, Evans Syndrome
- Trial name
- NCT07175493
- Testing
- CM336 Injection
- Where
- 3 sites in China
- Volunteers
- 158 people
- Sponsor
- Keymed Biosciences Co.Ltd
Autoimmune Thrombocytopenia, Warm Autoimmune Haemolytic Anaemia
IASO-782 in Autoimmune Hematological Diseases
This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases.
- Trial name
- NCT06534021
- Testing
- IASO-782 injection
- Where
- 2 sites in China
- Volunteers
- 16 people
- Sponsor
- Shanghai IASO Biotechnology Co., Ltd
Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1/2 trial evaluating the safety and preliminary efficacy of CTX112 or Zugocabtagene geleucel (zugo-cel) in adult participants with relapsed/refractory primary…
- Conditions
- Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Immune Thrombocytopenic Purpura
- Trial name
- NCT07549698
- Testing
- CTX112
- Where
- 12 sites in United States, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- CRISPR Therapeutics AG
Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia (AIHA)
Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)
This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease
- Trial name
- NCT07629596
- Testing
- Arnovie101 Infusion Intravenous
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Circunited BioPharma (Shenzhen) Co., Ltd.