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

NCT07071909 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: LCCC2337
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Chimeric antigen receptor (CAR)-T cell therapy; cell therapy; Chimeric antigen receptor (CAR)-T; infection; vaccine response

Outcome Measures

Primary Outcomes (1)

• Anti-pneumococcal antibody concentrations

  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.

  Baseline, 3 and 6 months post vaccination

Secondary Outcomes (2)

• Number of reconstitution clinic visits

  Up to 1 year

• Difference in infection density

  Up to 1 year

Study Arms (2)

Commercial CAR-T

EXPERIMENTAL

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

Biological: Commercial CAR-T

Investigational CAR-T

EXPERIMENTAL

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

Biological: Investigational CAR-T

Interventions

Commercial CAR-T BIOLOGICAL

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

Commercial CAR-T

Investigational CAR-T BIOLOGICAL

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

Investigational CAR-T

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
• The subject is willing and able to comply with study procedures based on the judgment of the investigator.
• Age ≥ 18 years at the time of consent.
• 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
• Agree to provide blood samples as required by the protocol
• Willing and able to provide access to immunization history
• If receiving CAR-T as part of a clinical trial, must meet all eligibility criteria for that trial
• Be willing to attend Immune Reconstitution Clinic Visits at 3, 6, 9, 12 months after CAR T-cell infusion
• Be willing to receive PCV-21 vaccination at 6 months after CAR T-cell infusion.

You may not qualify if:

• None

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms; Lymphoma; Leukemia; Multiple Myeloma; Infections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Natalie Grover, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: January 20, 2025
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)