ClinicalTrials.gov record NCT06921980
Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia
Brain Function and Psychological Assessment in Patients With Autoimmune Hemolytic Anemia Undergoing Cell Therapy
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective study follows people with relapsed/refractory autoimmune hemolytic anemia (AIHA) who receive cell therapy such as CAR T-cell treatment. It measures brain activity and psychological status before treatment and repeatedly during the first 28 days afterwards. The goal is to document any short-term changes in cognition, mood, sleep, and fatigue related to the cell therapy.
What it is studying. Whether and how cell therapy for AIHA is associated with short-term changes in brain function (measured by fNIRS) and psychological measures (personality, anxiety, depression, sleep, fatigue).
What the researchers hope to learn. To describe brain oxygenation changes and psychological symptom changes after cell therapy in AIHA patients, and to gather data that could inform safer monitoring and management strategies in future research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Brain function and psychological assessment
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving written informed consent, participants have a baseline assessment before their planned cell therapy and repeat assessments on Days 1, 4, 7, 10, 14, 21 and 28 after treatment. Assessments include non-invasive brain imaging with functional near-infrared spectroscopy (fNIRS) and several questionnaires measuring personality (BFI-2), anxiety (HAMA), depression (HAMD), sleep quality (PSQI) and fatigue (FACIT‑Fatigue). The registry record lists these scheduled, non-invasive assessments and does not list invasive procedures.
How the study is structured. A prospective observational cohort: participants are assessed before cell therapy and again on Days 1, 4, 7, 10, 14, 21, and 28 after treatment. Assessments include non‑invasive brain imaging (functional near‑infrared spectroscopy, fNIRS) and standardized questionnaires for personality, anxiety, depression, sleep quality, and fatigue. No treatment is assigned by the study; it records changes over time around the planned clinical cell therapy.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Feb 25, 2025
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2026 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Aug 5, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Collaborators
- Tianjin University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Zhexiang Kuang, MSN 📞 13920361752 ✉ kuangzhexiang@ihcams.ac.cn
- Xiao Yu, Undergraduate 📞 18722218448 ✉ yuxiao@ihcams.ac.cn
Participating sites (1)
- Regenerative Medicine CenterRecruiting
Tianjin, Tianjin Municipality · China
- Xiao Yu, Undergraduate · 18722218448 · yuxiao@ihcams.ac.cn
Terms used on this page · explanations by MedicalUpdates.ai
- CAR T
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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