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

Not Applicable

Not yet recruiting

• Conditions: Malignancy; Cancer; Hematological Malignancies; Lymphoma; Leukemia; Multiple Myeloma; Solid Tumor
• Interventions: Biological: Commercial CAR-T; Biological: Investigational CAR-T

• Registration Number: NCT07071909
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Study Start: 2025-08-01
• Primary Completion: 2029-02
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Commercial CAR-T	Commercial CAR-T	Twenty subjects who are receiving commercial CAR-T for CD19 or BCMA.
Investigational CAR-T	Investigational CAR-T	Thirty subjects are 30 receiving investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.

Primary Outcome Measures

Name	Time	Method
Anti-pneumococcal antibody concentrations	Baseline, 3 and 6 months post vaccination	Anti-pneumococcal titers will be measured in CAR-T patients to determine proportion of patients receiving either CD19 or BCMA-directed CAR-T vs CD30 or solid tumor CAR-T who respond to PCV21 vaccination.

Secondary Outcome Measures

Name	Time	Method
Number of reconstitution clinic visits	Up to 1 year	Number of reconstitution clinic visits (PCP prophylaxis including sulfamethoxazole trimethoprim, pentamidine, daponse, or atovqaqune and HSV proprophylaxis including valacyclovir or acyclovir) compared to historic controls.
Difference in infection density	Up to 1 year	Difference in infection density of patients within one year post CAR-T cell therapy infusion who attend Immune Reconstitution Clinic Visits compared to historic controls.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States