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RecruitingObservational

Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkins Lymphoma Post CAR-T Treatment

NCT ID: NCT06784167Sponsor: OHSU Knight Cancer InstituteLast updated: 2025-09-15

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.

Arms & interventions

  • OtherNon-Interventional Study

    Non-interventional study

Outcome measures

Primary

  • Preserved immunity

    Will be defined as titers that meet the definition of positive both pre- and post-CAR-T cell infusion. The proportion of subjects who have preserved immunity to each VPD will be estimated with an exact 95% confidence interval.

    Time frame: Up to 12 months after CAR-T cell infusion

Secondary

  • Change in antibody titers

    Time frame: At baseline, at 6 months and at 1 year after vaccination

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239

Recruiting
Amrita Desai · Contact
Amrita Desai · Principal Investigator
Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment | Cancerify