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NCT06784167Recruiting

Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment

OHSU Knight Cancer Institute

Start Date

3/10/2025

Completion Date

4/12/2027

Summary

This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.

Detailed Description

PRIMARY OBJECTIVES: I. To assess positive VPD antibody (Ab) titers prior to and at 6 months after CAR-T therapy to evaluate the impact of CAR-T on immune responses in patients undergoing CAR-T therapy. II. To assess the change in Ab titer to S. pneumoniae and tetanus at 6 months and 1 year post-vaccination and evaluate if titer increases are correlated to post-vaccination CD4+ count and IgG level. OUTLINE: This is an observational study. Patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * \* Willingness to provide written informed consent before any study-specific procedures or activities are performed * Age ≥ 18 years of age, at the time of consent * Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed * History of prior vaccination against common VPD * Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days * Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus Exclusion Criteria: * \* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints * Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable

Interventions

OTHER

Non-Interventional Study

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Conditions

Chronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular LymphomaMantle Cell LymphomaMultiple MyelomaPrimary Mediastinal Large B-Cell LymphomaSmall Lymphocytic Lymphoma

Locations

OHSU Knight Cancer Institute

Portland, Oregon 97239

United States