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Recruiting NCT06921980

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brain function and psychological assessment.
Who it may be relevant to
Registry conditions: CAR T-cell Therapy, Autoimmune Hemolytic Anemia, Brain Function, Psychological Well-Being. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Brain Function and Psychological Assessment in Patients With Autoimmune Hemolytic Anemia Undergoing Cell Therapy

Overview

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

  • 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.

Primary outcome measures

  • Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR) [Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.]
  • Psychological change [Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.]
  • Anxiety symptoms [Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.]
  • Depression symptoms [Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.]
Secondary outcome measures (2)
  • Sleep quality [Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.]
  • Physical fatigue [Time frame: Patients will be assessed before cell therapy and on Days 1, 4, 7, 10, 14, 21, and 28 after treatment.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Regenerative Medicine Center — Tianjin

Identifiers

NCT: NCT06921980 · QTJC2025011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗