Autoimmune Hemolytic Anemia, AIHA

8

Review clinical trials related to Autoimmune Hemolytic Anemia, AIHA. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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. It will also learn about the efficacy of HY001N cell injection to treat adult patients with autoimmune hemolytic anemia. The main questions it aims to answer are: Proportion of participants attaining a CR (defined as normalization of hemoglobin not attributed to transfusion effect and the normalization of hemolytic markers) or CRi (defined as normalization of hemoglobin not attributed to transfusion effect without normalization of hemolytic markers) after HY001N infusion? Proportion of participants attaining a PR (defined as hemoglobin ≥ 100 g/L or at least ≥ 20 g/L increase from baseline not attributed to transfusion effect) after HY001N infusion. • What medical problems do participants have when taking HY001N cell injection? Researchers will see if HY001N cell injection works to treat autoimmune hemolytic anemia. Participants will: * Take apheresis, lymphodepletion regimen and HY001N cell injection. * Visit the clinic on schedule.

Participants needed: 9
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Juventas Cell Therapy Ltd.Updated: Aug 5, 2026Locations: 1
Eligibility criteria

Participant and/or participant's legal representative fully understand and volun... [+5]

History of lymphoproliferative neoplasms [+18]

Status: Recruiting

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. Interim analysis conducted when 2 patients complete primary endpoint measurement.

Participants needed: 28
Trial details
Phase: Early Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Grit BiotechnologyUpdated: Jul 20, 2026Locations: 2
Eligibility criteria

Aged 18 to 75 years (inclusive), male or female; [+5]

Participants with a history of central nervous system leukemia/lymphoma, or thos... [+13]

Status: Not yet recruiting

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

Participants needed: 18
Trial details
Phase: Early Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUpdated: Jul 8, 2026Locations: 1
Eligibility criteria

Aged 18 to 75 years, regardless of genders. [+9]

Previously diagnosed definite lymphoproliferative neoplasms; other malignant tum... [+17]

Status: Recruiting

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. Treatment can be discontinued if ineffective at 12 weeks. Group B (100mg group): Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety. 2. cAIHA Treatment Regimen: Group C (150mg group): Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.

Participants needed: 50
Trial details
Phase: Phase 2Age: 18-85Biological sex: AllType: InterventionalSponsor: Peking Union Medical College HospitalUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years. [+5]

Active involvement of other major organs due to connective tissue disease. [+11]

Status: Recruiting

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

Participants needed: 5
Trial details
Phase: Early Phase 1Age: 18-60Biological sex: AllType: InterventionalSponsor: Circunited BioPharma (Shenzhen) Co., Ltd.Updated: Jun 5, 2026Locations: 1
Eligibility criteria

Ability to voluntarily sign informed consent, including compliance with the requ... [+3]

Presence of an unresected thymoma. [+18]

Status: Not yet recruiting

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 receptor signaling pathway and inhibiting B cell activation and proliferation, for the treatment of refractory immune-related cytopenia. In this study, it includes the salvage treatment of immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), expecting to achieve a synergistic and enhancing effect. This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options. The clinical efficacy of the Zuberitamab-Orelabrutinib combination therapy (overall response rate, duration of sustained remission) will be evaluated, along with its safety profile (including infections, bleeding, cardiac toxicity), to provide a theoretical basis for their combined use in treating refractory immune-related thrombocytopenia (ITP and AIHA).

Participants needed: 30
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: Qi dengUpdated: May 22, 2026
Eligibility criteria

Diagnosed with refractory immune-related cytopenia, including immune thrombocyto... [+8]

Women who are pregnant (with positive urine/blood pregnancy test results) or bre... [+13]

Status: Not yet recruiting

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 (glucocorticoid combined with sirolimus) or the control group (glucocorticoid monotherapy). The initial dose of sirolimus in the experimental group was 1mg/d, adjusted according to the blood drug concentration. The target concentration was 4-12ng/mL, and the treatment course was 6 months. Both groups of hormones were gradually reduced according to the standard protocol. All patients were followed up for 24 months, and the differences between the two groups at endpoints such as the hormone-free sustained response rate at the 12th month were compared.

Participants needed: 216
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Chen MiaoUpdated: Apr 8, 2026Locations: 1
Eligibility criteria

Age ≥18 years old, gender not limited; [+7]

Pregnant or lactating patients; [+9]

Status: Recruiting

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. There is a lack of comprehensive and large-scale prospective cohort studies in hematology. The purpose of this study is to analyze the incidence and risk factors of major blood diseases, the treatment methods, prognosis and medical expenses of these patients in China. Method The study will include patients diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders, autoimmune hemolytic anemia, large granular lymphocyte leukemia, essential thrombocythemia, blood infection or received bone marrow transplantation in the investigating hospitals from January 1, 2020, and collect basic information, diagnostic and treatment information, prognosis information, as well as medical expense information from medical records. In its current form, the NICHE registry incorporates historical data (collected from 2000) and is systematically collecting prospective data in two phases with broadening reach, and prospectively follow-up to collect the prognosis information.

Participants needed: 2,300
Trial details
Biological sex: AllType: ObservationalSponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUpdated: Feb 12, 2026Locations: 1
Eligibility criteria

Patients who were diagnosed with acute myeloid leukemia, multiple myeloma, hemop...

Long-term follow-up information for patients is not available for any reason, su... [+2]