Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT06921980
Recruiting Observational

Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia

NCT06921980 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Observational
Started
2025-02-25
Last updated
2026-11-04

Condition(s) studied

CAR T-cell TherapyAutoimmune Hemolytic AnemiaBrain FunctionPsychological Well-Being

Investigational drug(s) / intervention(s)

Brain function and psychological assessment

Brain function and psychological assessment: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

Study summary

Cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. Although it offers potential benefits for autoimmune hemolytic anemia (AIHA), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior.

Brain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. This study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on AIHA patients to develop safer and more effective treatment strategies that enhance their quality of life.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of AIHA * Subjects will receive cell therapy such as CAR T-cell therapy * Male or female, aged 18-65 years * Willing and able to comply with the requirements for this study and written informed consent Exclusion Criteria: * History of psychiatric illness * History of severe brain disease * Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study

Primary outcome measure(s)

  • Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR) — Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
    Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations.
  • Psychological change — Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
    The Big Five Inventory-2(BFI-2) is used to measure the five broad dimensions of personality: openness, conscientiousness, extraversion, agreeableness, neuroticism. Higher scores indicate a stronger presence of that personality trait.
  • Anxiety symptoms — Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
    Hamilton anxiety scale(HAMA) is used to examine anxiety in AIHA patients, with higher total scores indicate more severe anxiety symptoms. The total score range is 0-56.
  • Depression symptoms — Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
    Hamilton depression scale(HAMD) is used to examine depression in AIHA patients, with higher total scores indicate more severe depression symptoms. The total score range is 0-52.

Trial sites (1)

FacilityCityRegionStatus
Regenerative Medicine Center Tianjin Tianjin Municipality Recruiting

More Institute of Hematology & Blood Diseases Hospital, China trials in China

R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma Recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia. Active, not recruiting
Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model Recruiting
MRD-positive AML Clinical Study Recruiting
Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT Recruiting

Other trials for the same condition

Research on YTS109 Cell in Patients With Recurrent/Refractory Autoimmune Hemolytic Anemia Starting soon
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia Active, not recruiting
F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia Recruiting
Brain Cognitive Network Abnormalities in Anemia Patients Using fNIRS Recruiting
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921980 on ClinicalTrials.gov ↗ ← All trials in China