Characterization, long-term outcome, mechanisms, and treatment of CAR-T cell therapy-associated neurotoxicity

Recruiting

• Conditions: C83.3; C90.0; G04.2; G37.9; A85.8; Diffuse large B-cell lymphoma; Multiple myeloma; Bacterial meningoencephalitis and meningomyelitis, not elsewhere classified; Demyelinating disease of central nervous system, unspecified; Other specified viral encephalitis

• Registration Number: DRKS00031604
• Lead Sponsor: Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

informed written consent
- Patient is capable of giving consent (capable of understanding the nature and expected benefits and risks of the proposed investigations)
- Minimum 18 years of age
- sufficient health insurance coverage
- Karnofsky Index =70%
- The participant belongs to one of the following groups:
# Patients/ patients with underlying hemato-oncologic disease for whom CAR T-cell therapy is planned.
# Patients with malignant hemato-oncological disease (preferably lymphoma, leukemia, multiple myeloma)
# healthy volunteers
# Patients with suspected CNS infection undergoing diagnostic lumbar puncture
# Patients with suspected or confirmed autoimmunological CNS disease undergoing diagnostic lumbar puncture.
- For cohorts 1-3: fluent in written and spoken German language

Exclusion Criteria

- The patient is not willing to consent to the storage, processing and disclosure of pseudonymized medical data for study purposes
- The patient is under legal care or lawfully placed in an official institution
- To be applied for cohort 1-3 only:
# The patient has pre-existing (dementia, identifiable by a MOCA score of <15/30 pts.)
# The patient has a history of florid alcohol and/or drug abuse.
# The patient is currently suffering from a moderately depressive episode (recognizable by a BDI-FS score of =4 pts.)
# The patient has a pacemaker or a non-MRI capable implant.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean z-scores of different subtests of a standardized neuropsychological examination at V1 (baseline, approx. 1-4 weeks before CAR-T cell infusion) and at V3 (approx. 6 months after CAR-T cell infusion). The z-scores at V3, adjusted to the baseline level at V1, are compared between patients with ICANS and patients without ICANS.