Clinical trials: Autoimmune Hemolytic Anemia (AIHA)
Autoimmune Hemolytic Anemia, CD19/BCMA CAR T-cells
CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in AIHA who have failed ≥ 3 lines of therapy.
- Conditions
- Autoimmune Hemolytic Anemia, CD19/BCMA CAR T-cells, Universal Allogeneic CAR T-cells
- Trial name
- NCT06733610
- Testing
- universal allogeneic anti-CD19/BCMA CAR T-cells
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Anti Phospholipid Syndrome
Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
AIHA is a heterogeneous autoimmune cytopenia with variable severity and significant morbidity. APS is defined by thrombosis and/or obstetric morbidity with persistent antiphospholipid antibodies (aPL).
- Trial name
- NCT07743242
- Testing
- Hemoglobin, Coombs test
- Where
- Egypt
- Volunteers
- 230 people
- Sponsor
- New Valley University
Autoimmune Hemolytic Anemia, Immune Thrombocytopenia
A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
This is a Phase 2 randomized, dose-blind, multicenter study designed to evaluate the safety, tolerability, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) of treatment with KZR-616 in patients with active Autoimmune…
- Trial name
- MARINA (NCT04039477)
- Testing
- KZR-616
- Where
- 22 sites in United States, Australia and 3 more
- Sponsor
- Kezar Life Sciences, Inc.
Autoimmune Hemolytic Anemia (AIHA)
META 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia
- Trial name
- NCT07689604
- Testing
- Metabolically Armed Autologous CD19 CAR T-Cell therapy
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Chronic Lymphocytic Leukemia
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL) That Did Not Respond to Fludarabine, CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00309881
- Testing
- rituximab, cyclophosphamide, doxorubicin hydrochloride
- Where
- 18 sites in Germany
- Volunteers
- 75 people
- Sponsor
- German CLL Study Group
AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia
OM336 in Autoimmune Cytopenias
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
- Trial name
- NCT07083960
- Testing
- OM336
- Where
- 7 sites in United States, Australia
- Volunteers
- 32 people
- Sponsor
- Lakefront Biotherapeutics West LLC
Refractory/Relapsed Autoimmune Hemolytic Anemia
The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.
- Trial name
- NCT04398459
- Testing
- Ibrutinib
- Where
- 3 sites in China
- Volunteers
- 18 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Autoimmune Hemolytic Anemia (AIHA)
A Multicenter, Prospective, Randomized Controlled Study Comparing Glucocorticoid Combined With Sirolimus With Monotherapy of Glucocorticoid in the Treatment of Newly Diagnosed Mild Autoimmune Hemolytic Anemia
This study is a prospective, multicenter, randomized controlled trial. A total of 216 adult patients with newly diagnosed wAIHA were planned to be included and randomly assigned in a 1:1 ratio to the experimental group…
- Trial name
- sirolimus (NCT07518277)
- Testing
- Glucocorticoids
- Where
- China
- Volunteers
- 216 people
- Sponsor
- Chen Miao
Warm Antibody Autoimmune Hemolytic Anemia
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
- Trial name
- SOAR (NCT02612558)
- Testing
- Fostamatinib 150 mg bid
- Where
- 36 sites in United States, Canada
- Volunteers
- 26 people
- Sponsor
- Rigel Pharmaceuticals
Anti-CD20 Monoclonal Antibody, BTK Inhibitors
CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia
This study aims to utilize anti-CD20 monoclonal antibodies to eliminate peripheral B cells and reduce the mechanism of autoantibody production, as well as combine the mechanism of BTK inhibitors (BTKi) blocking the B cell…
- Conditions
- Anti-CD20 Monoclonal Antibody, BTK Inhibitors, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia (AIHA)
- Trial name
- NCT07574073
- Testing
- Anti-CD20 monoclonal antibody and the BTK inhibitor
- Volunteers
- 30 people
- Sponsor
- Qi deng
AIHA - Warm Autoimmune Hemolytic Anemia
Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia
This is an open-labeled, single arm, Phase II, two staged study of combination of ibrutinib and rituximab in patients with autoimmune cytopenia and underlying CLL.
- Trial name
- ISRAEL (NCT03827603)
- Testing
- Ibrutinib
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Eugene Nikitin
Warm Autoimmune Hemolytic Anemia
Rituximab in Auto-Immune Hemolytic Anemia
The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be…
- Trial name
- RAHIA (NCT01181154)
- Testing
- rituximab (Mabthera®)
- Where
- France
- Volunteers
- 32 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia
A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)
To evaluate the efficacy and safety of ipecopam in the treatment of refractory/relapsed AIHA.
- Trial name
- NCT06847607
- Testing
- Iptacopan
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Bing Han
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.
AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia
National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia Mixed Type
- Trial name
- NICHE-AIHA (NCT07019038)
- Testing
- A combined retrospective and prospective observational follow-up
- Where
- China
- Volunteers
- 9,999 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
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
Autoimmune Hemolytic Anemia, Primary Immune Thrombocytopenic Purpura
UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated…
- Conditions
- Autoimmune Hemolytic Anemia, Primary Immune Thrombocytopenic Purpura, Evans Syndrome
- Trial name
- NCT07441525
- Testing
- CART Infusion
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Autoimmune Hemolytic Anemia
Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease.
- Trial name
- TFH and AIHA (NCT02828670)
- Testing
- blood sample, spleen sample
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Autoimmune Hemolytic Anemia
Data Registry of Auto Immune Hemolytic Anemia
In autoimmune hemolytic anemia (AIHA) auto-antibodies directed against red blood cells (RBCs) lead to increased RBC clearance (hemolysis). This can result in a potentially life-threatening anemia.
- Trial name
- DRAIHA (NCT04024202)
- Where
- 2 sites in Netherlands
- Volunteers
- 720 people, healthy volunteers welcome
- Sponsor
- Sanquin Research & Blood Bank Divisions
Autoimmune Hemolytic Anemia (AIHA)
Orelabrutinib in the Treatment of Relapsed/Refractory AIHA
1. wAIHA Treatment Regimen: Group A (50mg group): Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is < 20 g/L, the dose may be increased to 100 mg qd.
- Trial name
- NCT07453368
- Testing
- Orelabrutinib-50, Orelabrutinib-100, Orelabrutinib-150
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking Union Medical College Hospital