Clinical trials: Autoimmune Hemolytic Anemia (AIHA), active
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
Warm Autoimmune Hemolytic Anemia
Sirolimus in the Treatment of Refractory/Relapsed wAIHA
Autoimmune hemolytic anemia (AIHA) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. Glucocorticoid (combined with rituximab) is the first-line treatment.
- Trial name
- NCT05925023
- Testing
- Sirolimus
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Peking Union Medical College Hospital
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.
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
AIHA - Warm Autoimmune Hemolytic Anemia, UCART
UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
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
- Trial name
- NCT07530380
- Testing
- QT-219C Cell Injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Second Hospital of Anhui Medical University
Autoimmune Hemolytic Anemia, Immune Thrombocytopenia
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune…
- Conditions
- Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, Chronic Idiopathic Neutropenia, Autoimmune Neutropenia
- Trial name
- AIHA ITP CIN (NCT05931718)
- Testing
- cytokine essays, NGS, Fecal microbiome
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
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
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
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
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
Multiple Myeloma, Acute Myeloid Leukemia
National Longitudinal Cohort of Hematological Diseases
Background 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
- Multiple Myeloma, Acute Myeloid Leukemia, Hemophilia, Hemophilia A
- Trial name
- NICHE (NCT04645199)
- Where
- China
- Volunteers
- 2,300 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
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
- 5 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
AIHA - Cold Autoimmune Hemolytic Anemia
Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy
This is a multicenter, open-label, single-arm Phase I clinical trial to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection treatment in autoimmune hemolytic anemia that has failed at least three lines of…
- Trial name
- NCT07091370
- Testing
- Inaticabtagene Autoleucel Injection
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
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
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
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
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
Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
This is a multicenter, single arm, phase II study aimed at evaluating ibrutinib therapy for the treatment of AIHA in patients with CLL/SLL or CLL-like MBL.
- Conditions
- Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Monoclonal B-Cell Lymphocytosis CLL-Type
- Trial name
- NCT05694312
- Testing
- Ibrutinib 420 mg
- Where
- 3 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
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.