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

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Hemolytic Anemia; Brain Function; Psychological Well-Being; CAR T-cell Therapy
• Intervention / Treatment: Other: Brain function and psychological assessment

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: ZheXiang Kuang, MSN; Phone Number: 13920361752; Email: kuangzhexiang@ihcams.ac.cn
• Study Contact Backup: Name: Xiao Yu, Undergraduate; Phone Number: 18722218448; Email: yuxiao@ihcams.ac.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Regenerative Medicine Center
      • Contact: Xiao Yu, Undergraduate; Phone Number: 18722218448; Email: yuxiao@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed/refractory AIHA who will receive cell therapy, such as CAR T-cell therapy, from 2025 to 2026.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Brain function and psychological changes in AIHA patients will be monitored throughout cell therapy.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)	Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations.	Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
Psychological change	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.	Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
Anxiety symptoms	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.	Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
Depression symptoms	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.	Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality, with a higher global score indicating poorer sleep quality. The global score range is 0-21.	Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
Physical fatigue	It measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. The total possible score is 0-52 points, with higher scores indicating less fatigue.	Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Collaborators: Tianjin University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Hematologic Diseases; Anemia; Hemolysis; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune
• Other Study ID Numbers: QTJC2025011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No