Clinical trial NCT06921980: Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia
Official title: Brain Function and Psychological Assessment in Patients With Autoimmune Hemolytic Anemia Undergoing Cell Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CAR T-cell Therapy
Autoimmune Hemolytic Anemia
Brain Function
Psychological Well-Being
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Tianjin University
First posted: 2025-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 outcomes:
measure: Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)
timeFrame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
measure: Psychological change
timeFrame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
measure: Anxiety symptoms
timeFrame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
measure: Depression symptoms
timeFrame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
Secondary outcomes:
measure: Sleep quality
timeFrame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
measure: Physical fatigue
timeFrame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Regenerative Medicine Center
state: Tianjin
Study officials:
References: