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

NCT06921980 | Recruiting

• 1 other identifier: QTJC2025011
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CAR T-cell Therapy; Autoimmune Hemolytic Anemia; Brain Function; Psychological Well-Being

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Sleep quality

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

• Physical fatigue

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

Study Arms (1)

Experimental

Brain function and psychological changes in AIHA patients will be monitored throughout cell therapy.

Other: Brain function and psychological assessment

Interventions

Brain function and psychological assessment OTHER

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

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• History of psychiatric illness
• History of severe brain disease

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Tianjin University: collaborator

Study Sites (1)

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune; Psychological Well-Being

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction; Behavior

Central Study Contacts

Zhexiang Kuang, MSN

CONTACT

13920361752; kuangzhexiang@ihcams.ac.cn

Xiao Yu, Undergraduate

CONTACT

18722218448; yuxiao@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 10, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)