Clinical trials: Autoimmune Haemolytic Anaemia, active
Warm Antibody Autoimmune Hemolytic Anemia
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA. Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.
- Trial name
- wAIHA (NCT05535933)
- Testing
- HMPL-523(300mg PO QD)
- Where
- 39 sites in China
- Volunteers
- 111 people
- Sponsor
- Hutchmed
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 START T-cell therapy…
- Conditions
- Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy, Failure ≥3 Lines of Therapies
- Trial name
- NCT06770504
- Testing
- YTS109
- Volunteers
- 7 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Immune Thrombocytopenia
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
- Trial name
- NCT07104565
- Testing
- INCA000585
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 56 people
- Sponsor
- Incyte Corporation
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
Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (WAIHA)
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
A Phase 1b/2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune…
- Trial name
- NCT07738822
- Testing
- Velinotamig specified dose on specified days.
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Cullinan Therapeutics Inc.
Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
This phase II trial studies the effect of acalabrutinib in treating autoimmune hemolytic anemia that has come back (relapsed) or has not responded to previous treatment (refractory) in patients with chronic lymphocytic leukemia.
- Conditions
- Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Warm Antibody Autoimmune Hemolytic Anemia
- Trial name
- NCT04657094
- Testing
- Acalabrutinib
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- City of Hope Medical Center
Autoimmune Hemolytic Anemia
A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al.
- Trial name
- NCT07190261
- Testing
- enatumab
- Where
- China
- Volunteers
- 3 people
- Sponsor
- Bing Han
Extrahepatic Portal Vein Obstruction (EHPVO), Thrombophilia
Hematological Disorders in EHPVO Patients
This study focuses on patients who have a condition called extrahepatic portal vein obstruction (EHPVO), where a blood clot blocks the portal vein outside the liver.
- Conditions
- Extrahepatic Portal Vein Obstruction (EHPVO), Thrombophilia, Myeloproliferative Neoplasms (MPN), Antiphospholipid Syndrome (APS)
- Trial name
- EHPVO-HEM (NCT07108023)
- Testing
- No intervention (Observational Study)
- Volunteers
- 115 people
- Sponsor
- Rahab Nady
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 (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
Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes
Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC
This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft…
- Conditions
- Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias
- Trial name
- PRO-RIC (NCT04528355)
- Testing
- data collection
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paul Szabolcs
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
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
Relapsed / Refractory Autoimmune Hemolytic Anemia
UCAR T-cell Therapy Targeting CD19/BCMA in Patients With r/r Autoimmune Hemolytic Anemia
This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Autoimmune hemolytic anemia.
- Trial name
- NCT06920446
- Testing
- UCAR T-cell group
- Volunteers
- 18 people
- Sponsor
- Zhejiang University
Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
This study is an open-label, single-arm, prospective, multicenter, phase I/II clinical trial. It adopts the two-stage optimal design proposed by Bryant and Day to investigate the efficacy, safety, and in vivo pharmacokinetic…
- Trial name
- NCT07324889
- Testing
- CD19/BCMA CAR-T
- Volunteers
- 24 people
- Sponsor
- Yihao Wang
Warm Autoimmune Hemolytic Anemia
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
- Trial name
- ENERGY (NCT04119050)
- Testing
- M281
- Where
- 171 sites in United States, Brazil and 17 more
- Volunteers
- 118 people
- Sponsor
- Janssen Research & Development, LLC
Prolonged Anticoagulation, Venous Thromboembolic Disease
Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study
Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence <1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies.
- Conditions
- Prolonged Anticoagulation, Venous Thromboembolic Disease, Autoimmune Hemolytic Anemia
- Trial name
- API-AHAI (NCT05089227)
- Testing
- treatment "intervention", treatment "standard", biological assessment
- Where
- France
- Volunteers
- 72 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including…
- Conditions
- Antiphospholipid (aPL)-Positive, Rheumatic Arthritis, Celiac Disease, Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- MERIT (NCT07892651)
- Where
- Jordan
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Axiom Bioregistry
Warm Antibody Autoimmune Hemolytic Anemia
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
The primary objective of this study is: To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
- Trial name
- NCT04138927
- Testing
- Fostamatinib disodium
- Where
- 37 sites in United States, Australia and 16 more
- Volunteers
- 90 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