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

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well the immune system recovers after a special cancer treatment called CAR-T cell therapy, which is used to fight certain blood cancers and tumors. The study will look at whether regular clinic visits focused on immune health and giving a pneumonia vaccine (called PCV-21) six months after treatment can help lower the risk of infections, improve how well patients stick to infection prevention measures, and how well the vaccine works. Participants will have blood tests at several times over the first year after their CAR-T treatment to check their immune system and vaccine response. The study will also follow their health for up to two years through medical records.

People who may join this study are adults (18 years or older) who are planning to receive CAR-T therapy for cancers like lymphoma, leukemia, multiple myeloma, or certain solid tumors. To participate, they need to agree to attend scheduled clinic visits at 3, 6, 9, and 12 months after treatment, provide blood samples, and receive the pneumonia vaccine at 6 months. The extra vaccine and blood tests are the only additional parts of the study; all other cancer treatments will follow standard care or ongoing clinical trials. This study aims to help doctors better understand immune recovery and infection risks after CAR-T therapy, which could improve care for future patients.

Gender

ALL

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