Immune Reconstitution Monitoring and Pneumococcal Vaccination in Patients Treated With CAR-T Cells

NCT ID: NCT07071909

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-08-29

Brief Summary

This is a prospective interventional study designed to investigate the effect of Immune Reconstitution clinic visits and pneumococcal vaccination (PCV-21) on infection risk, anti-infective prophylaxis adherence, and vaccine response in patients receiving CAR-T therapy following lymphodepletion. Fifty subjects (20 receiving commercial CAR-T for CD19 or BCMA and 30 receiving investigational CAR-T) will be enrolled. Subjects will attend Immune Reconstitution Clinic Visits at 3, 6, 9, and 12 months after CAR-T cell infusion. Subjects will be asked to provide blood samples at pre-defined intervals during CAR-T visits which will be assessed for immune composition, vaccine titers, viral titers, and immunoglobulins. Samples will be primarily used for study purposes. Leftover blood will be stored for up to five years after the last study visit and may be used for future research.

Vaccination against pneumococcal pneumonia will be offered at 6 months post-CAR-T infusion at the Immune Reconstitution Clinic Visit. Subjects will provide additional blood samples at 9- and 12 months post CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies to determine vaccine efficacy.

Long-term follow-up will continue for up to 24 months post-CAR-T infusion via medical chart abstraction.

This pilot study investigates immune reconstitution, infection risk, and vaccine response in patients receiving chimeric antigen receptor (CAR)-T cell therapy following lymphodepletion. Subjects will undergo lymphodepletion followed by CAR-T cell infusion will be included. The only additional treatment for subjects in this study is the PCV-21 pneumococcal vaccine. All CAR-T treatment procedures will adhere to the standard-of-care or the clinical trial protocol to which the subject is co-enrolled.

Subjects will provide blood samples at predefined intervals during CAR-T visits. These samples will be assessed for various laboratory studies, including blood counts, immune cell composition, viral titers, immunoglobulins, and microbiome composition.

Vaccination against pneumococcal pneumonia will be given 6 months post-CAR-T- T infusion. Subjects who opt for this vaccination will provide additional blood and blood samples at collected at 6, 9, and 12 months post-CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies. Long-term follow-up will continue for up to 24 months post-CAR-T infusion through medical chart abstraction

Conditions

Malignancy; Cancer; Hematological Malignancies; Lymphoma; Leukemia; Multiple Myeloma; Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Commercial CAR-T

Twenty subjects who are receiving commercial CAR-T for CD19 or BCMA.

Group Type: EXPERIMENTAL

Commercial CAR-T

Intervention Type: BIOLOGICAL

Twenty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.

Investigational CAR-T

Thirty subjects are 30 receiving investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.

Group Type: EXPERIMENTAL

Investigational CAR-T

Intervention Type: BIOLOGICAL

Thirty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.

Interventions

Commercial CAR-T

Twenty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.

Intervention Type: BIOLOGICAL

Investigational CAR-T

Thirty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.

2. The subject is willing and able to comply with study procedures based on the judgment of the investigator.

3. Age ≥ 18 years at the time of consent.

4. Planning to receive a commercial CD19 or BCMA-directed CAR-T therapy or investigational CD30 or solid tumor CAR-T therapy as a single infusion following lymphodepletion

5. Agree to provide blood samples as required by the protocol

6. Willing and able to provide access to immunization history

7. If receiving CAR-T as part of a clinical trial, must meet all eligibility criteria for that trial

8. Be willing to attend Immune Reconstitution Clinic Visits at 3, 6, 9, 12 months after CAR T-cell infusion

9. Be willing to receive PCV-21 vaccination at 6 months after CAR T-cell infusion.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Grover, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

Clinical trials at UNC Lineberger

Other Identifiers

LCCC2337

Identifier Type: -

Identifier Source: org_study_id